Scandinavian Journal of Urology. 2014; 48: 301–308
ORIGINAL ARTICLE
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Umbilical laparoendoscopic urological surgery with a novel reusable device
ANA GARCÍA-TELLO, PEDRO M. CABRERA, FELIPE CÁCERES, FERNANDO RAMÓN DE FATA, ERIKA MATEO & JAVIER C. ANGULO Department of Urology, Hospital Universitario de Getafe, Fundación para la Investigación Biomédica, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Madrid, Spain
Abstract Objective.The aims of this study were to present cumulative experience with umbilical laparoendoscopic urological surgery using a reusable device and to evaluate outcomes and complications in the first 100 patients. Material and methods. Patients undergoing umbilical surgery with the KeyPort system and DuoRotate instruments (Richard Wolf, Knittlingen, Germany) were evaluated prospectively. Demographic, intraoperative and postoperative data were assessed. Results.Between October 2011 and July 2012, 79 pelvic (66 radical prostatectomy, 10 radical cystectomy, one diverticulectomy, one bilateral orchiectomy, one ureter reimplantation) and 21 renal (seven radical nephrectomy, six partial nephrectomy, five nephroureterectomy, two pyeloplasty, one pyelolithotomy) surgeries were performed through the umbilicus using this platform. Followup was 56.7 ± 12.6 weeks (mean ± SD). Mean age was 64.3 ± 10.3 years, body mass index 29 ± 4.6 kg/m2, operative time 232 ± 106 min and estimated blood loss 260 ± 95 ml. Conversion to standard multiport laparoscopy was not necessary. An accessory port was used in 87 cases to facilitate suturing and conduct drainage extraction. Postoperative complications occurred in 24 cases (six Clavien grade I, 12 grade II, one grade IIIa, two grade IIIb, two grade IVa, one grade IVb). Mean hospital stay was 4.2 ± 4 days. Total transfusion rate was 10%. Mean visual analogue pain scale at day 2 was 2.1 ± 1.3 (0–10). Visual analogue wound satisfaction scale at month 1 was 9.2 ± 0.6 (0–10). No cancer-related events occurred during follow-up. Late complications (4%) were not related to the surgical approach. Conclusions.Umbilical KeyPort surgery is technically feasible for a great variety of procedures, both ablative and reconstructive. This access offers adequate surgical outcomes, scarce postoperative pain and security for the patient in the short term. Its reusable nature implies a noticeable economic advantage.
Key Words: complications, LESS, outcomes, umbilicus, urological surgery
Introduction Increased experience in laparoscopic surgery has led surgeons to direct their efforts towards improving safety for the patient, minimizing discomfort and shortening convalescence. Laparoendoscopic singlesite (LESS) surgery has developed as an evolution of minimally invasive surgery that brings the latest advantages in enhanced cosmetics and decreased pain compared with conventional laparoscopy with multiple trocars and specifically with regard to extraction of the specimen [1]. Multichannel single-access
ports and novel bent instruments allow surgery to be carried out through a single skin incision that can be hidden within the umbilicus; therefore, using this embryonic natural orifice gives the maximum aesthetic benefit and respect for the integrity of the abdominal wall [2]. Only a few years after Raman et al. published the first account of urological LESS surgery [3], this technique has become widely applied in different settings and for many different urological procedures [4–7]. Researchers have reported the feasibility and shortterm outcomes in their series; however, questions
Correspondence: J. C. Angulo, Hospital Universitario de Getafe, Carretera de Toledo Km 12,500, 28905 Madrid, Spain. Tel: +34 916247306. Fax: +34 916247309. E-mail: [email protected]
(Received 24 July 2013; revised 12 November 2013; accepted 4 December 2013) ISSN 2168-1805 print/ISSN 2168-1813 online 2014 Informa Healthcare DOI: 10.3109/21681805.2013.876096
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remain regarding both the potentially long learning curve and the comparative benefit in experienced hands between this technique and conventional or robot-assisted laparoscopy [8]. New technical developments, including robotic applications and more precise manual systems, are contributing to further promotion of the field [1,2,9], and the reusable nature of some of these platforms constitutes an economic advantage. The addition of mini-laparoscopy instruments through an accessory port facilitates surgery without a cosmetic impact as the residual scar of this orifice becomes invisible. The present authors have previously reported their initial developmental experience with this system in different urological procedures [10–13]. This article describes cumulative data regarding the first 100 patients undergoing umbilical surgery with a reduced port approach for both ablative and reconstructive procedures in this institution. Material and methods Study population A prospective observational study was performed in a university hospital to evaluate the feasibility and safety of different urological procedures using a reusable laparoendoscopic system placed in the umbilicus, in consecutive non-selected patients with an indication
for transperitoneal laparoscopic urological surgery who consented to this approach. All patients were operated on by the same surgical team (PMC and FC). The only exclusion criterion for this approach was that the patient preferred conventional multiport laparoscopy or open surgery. Previous abdominal surgery or radiation was not considered a contraindication for the technique. Operative results, outcomes and complications were evaluated. Patients’ data were entered in an institutional reviewed boardapproved database that included demographics, gender, patient age and body mass index (BMI).
Surgical technique The procedures were performed with a reusable KeyPort system placed inside the umbilicus, with the patient in the flank position for renal surgery and in the Trendelenburg position for pelvic procedures. A reusable rigid trocar is inserted in a screw-driven fashion through a 2.5 cm umbilical opening without the need for fixation or gas leakage (Figure 1). After removal of the inner element, the soft multichannel silicone seal cover with three openings (5, 10 and 15 mm) is closed to insert curved instruments with the DuoRotate system that allows precise 360 movement of the tip. A right-handed surgeon uses atraumatic prehension forceps with the left hand and
Figure 1. KeyPort fitting a 2.5 cm umbilical incision with instruments and lens inserted.
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Umbilical urological surgery Metzenbaum scissors with the right. The assistant holds the camera on a 5.7 mm wide, 50 cm long, 0 or 30 Panoview lens. Straight instruments, such as specific suction irrigation or Eragon forceps, can be combined. All the aforementioned elements are produced by Richard Wolf (Knittlingen, Germany). Additional instrumentation includes the ForceTriad electrosurgical device (5 or 10 mm; Covidien, Dublin, Ireland), Hem-o-lok (Teleflex, Research Triangle Park, NC, USA) clip applier and Endopouch Retriever (Johnson & Johnson, New Brunswick, NJ, USA). Owing to the absence of a specific needle holder, an ancillary 3.5 mm reusable port is incorporated in the iliac fossa (for pelvic surgery) or hypochondrium (for renal surgery) for all procedures that require suture (Figure 2). At this time, the surgeon holds the minilaparoscopy needle holder with the right hand and the DuoRotate forceps in the KeyPort on the left, while the assistant holds the camera and suction irrigation pump, also through the KeyPort. The accessory port is also used to insert the suction irrigation device and at the end of the procedure for drainage extraction. For radical cystectomy a 10 mm extra-port placed in the right iliac fossa is used to insert the suction irrigation system, perform urethral anastomosis in orthotopic reservoirs and extract drainage and bilateral ureteral stents. In no case were two or more extra ports needed. Manoeuvres to avoid additional port placement
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included marionette sutures coming out through the skin to retract hollow organs such as the bladder or colon, or very occasionally direct insertion of needlescopic instruments for liver or kidney retraction. Only rarely was it necessary to increase wound size to remove the surgical specimen and in those cases only the aponeurosis and not the skin was incised. Analysis Operative data recorded were estimated blood loss (EBL) in the operating room, haemoglobin difference calculated as postoperative day 2 minus preoperative day –14, time of surgery, conversion to standard laparoscopy, intraoperative transfusion rate and intraoperative complications. Postoperative transfusion rate, hospital stay, immediate postoperative adverse events and visual analogue pain scale (VAPS) scores at day 2 were also obtained. Patients were followed after discharge for evidence of remote adverse events and to receive the histological report. Patient satisfaction at 3–4 weeks was assessed on a visual analogue wound satisfaction scale (VAWSS), from 0 to 10, by the same doctor in the office. This scale was provided by showing the patient sketches of three different incisions (open incision in the form of lumbar or midline infraumbilical incision, laparoscopy with five ports and umbilical surgery with one additional port) through which surgery could have
Figure 2. Umbilical KeyPort and 3.5 mm reusable mini-laparoscopy port placed on the right iliac fossa.
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been performed, then immediately asking the patient to rate his or her own incision in terms of satisfaction with the wound [11,13]. Patients were also specifically followed for evidence of local umbilical adverse events and regarding cosmetic aspects of the wound at month 3. Surgical complications were classified according to the Clavien–Dindo scheme [14]. At the time of this report all cases had been contacted by telephone by the same doctor (AG) to rule out late events.
Results Between October 2011 and July 2012, 100 umbilical urological procedures using the KeyPort system were performed in the authors’ institution by two surgeons experienced in laparoscopic procedures (PMC and FC). They included 79 pelvic procedures (prostatectomy, n = 66; radical cystectomy, n = 10; diverticulectomy, n = 1; bilateral orchiectomy for androgen insensitivity syndrome, n = 1; ureteral reimplantation, n = 1) and 21 renal surgeries (radical nephrectomy, n = 7; partial nephrectomy, n = 6; nephroureterectomy, n = 5; pyeloplasty, n = 2; pyelolithotomy, n = 1). One accessory port was used in 87 cases (3.5 mm in 77 and 10 mm in 10), incorporated to ease intracorporeal suturing and facilitate drainage extraction in 78 out of 79 pelvic (98.7%) and nine out of 21 renal surgeries (42.9%). Procedures in which no suture was needed were driven through the KeyPort platform exclusively placed in the umbilicus through a 2.5 cm incision. Marionette sutures were used in 78 cases and direct insertion of needlescopic instruments in two. The bladder cuff during nephroureterectomy was performed through partial cystectomy and bladder closure. Nephron-sparing surgery used a clampless technique in four out of six cases. Orthotopic urinary diversion was performed in six out of 10 cases after radical cystectomy and ileal conduit in the rest. Ileoileal anastomosis and diversion was performed extracorporeally and the neobladder was reintroduced and laparoendoscopically anastomosed to the urethra. Surgery was successfully completed in all cases, without the need for conversion to standard multiport laparoscopy or open surgery. During the same period, 51 patients chose conventional multiport laparoscopy and 28 open procedures in this institution. The male to female ratio was 7.3:1 (male, n = 88; female, n = 12). For the entire cohort, the mean ± SD age was 64.3 ± 10.3 years and mean BMI 29 ± 4.6 kg/m2. The American Society of Anesthesiologists (ASA) score was I in 11%, II in 68%, III in 20% and IV
in 1%. Prior abdominal surgery had been performed in 17% of patients. The indication for surgery was oncological in 90 patients, reconstructive in five and ablative non-oncological in five. Mean operative time was 232 ± 106 min, EBL 260 ± 95 ml and haemoglobin difference 2.8 ± 1.3 g/dl. No intraoperative complications occurred and the intraoperative transfusion rate was 2% (radical cystectomy, n = 1; partial nephrectomy, n = 1). Mean hospital stay was 4.2 ± 4 days. There was no statistically significant difference in hospital stay between renal (3.3 ± 1.3 days) and pelvic surgery (4.5 ± 4.4 days) (p = 0.9). The mean VAPS score at day 2 (on a scale from 0 to 10) was 2.1 ± 1.3. During the immediate postoperative period, surgical minor complications occurred in 18% and major complications (grade III or higher) in 6%. No grade V complications were observed. Major complications were not more common during the early experience and were distributed throughout the experience. The postoperative transfusion rate was 8%. No cancer-related events have occurred during follow-up. Patient satisfaction with the wound based on the VAWSS (from 0 to 10), investigated at 1 month, was 9.2 ± 0.6. Complete demographic and outcome data are shown in Tables I and II. Pathology and early complications (within 1 month) are shown in Table III. Mean follow-up was 56.7 ± 12.6 weeks (range 35–78 weeks) at the time of this report. Late complications within this follow-up occurred in 4% and included bladder neck stricture, acute pyelonephritis, chronic renal insufficiency and chronic pyelonephritis, and pseudoaneurysm with arteriovenous fistula (one case each). Discussion Several variations have emerged to ease the major difficulties encountered during single-site surgery. Robot-assisted LESS may reduce some of the limitations and make complicated reconstructive procedures feasible [2,6]. However, wide adoption of this alternative would require redesign or development of new robotic platforms. The use of minilaparoscopy is another variation that does not compromise the concept of “scarless” surgery and constitutes the natural evolution of laparoscopy [15,16]. Multichannel ports are now better designed to offer more flexibility and the use of bent instruments allows triangulation and reduced internal and external clashing [1]. However, this approach remains technically challenging and a solid laparoscopic background is desirable before performing umbilical surgery routinely [17]. Advantages over laparoscopic
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Umbilical urological surgery Table I. Outcomes of umbilical laparoendoscopic upper urinary tract surgery.
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Procedure Radical nephrectomy
Partial nephrectomy
Nephroureterectomy
Pyeloplasty
Pyelolithotomy
No. of cases
7
6
5
2
1
Age (years)
67.4 ± 16.4
59.1 ± 15.3
64.8 ± 12.4
BMI (kg/m2)
29.9 ± 8.3
29.8 ± 7.1
25.6 ± 4.6
53 ± 22.6
42
23.7 ± 2.3
31.6
OT (min)
189 ± 37
206 ± 52
238 ± 55
190 ± 71
240
EBL (ml)
300 ± 141
400 ± 155
290 ± 134
137 ± 88
50
Hb difference (g/dl)
2.5 ± 1.6
2.12 ± 1.6
3.3 ± 1.4
2±0
0.6
Transfusion rate (%)
14.3
16.7
20
0
0
Hospital stay (days)
2.8 ± 0.9
2.8 ± 0.7
3.8 ± 1.9
3±0
2
VAPS
2.7 ± 0.7
1.2 ± 0.9
2.2 ± 0.8
1.5 ± 0.7
2
VAWSS
8.4 ± 0.8
9.1 ± 0.8
8.4 ± 0.9
9.5 ± 0.7
9
Data are shown as mean ± SD. BMI = body mass index; OT = operative time; EBL = estimated blood loss; Hb = haemoglobin; VAPS = visual analogue pain scale; VAWSS = visual analogue wound satisfaction scale.
surgery in selected patients and by experienced surgeons include superior cosmesis, decreased pain and quicker recovery, with no increase in operative time in experienced hands [18,19]. Disadvantages include the limited range of movements and increased cost if disposable devices are used. Placement of an accessory port optimizes exposure of the operative field and facilitates difficult tasks in advanced reconstruction [20,21]. Scarless (masked scar) surgery using a reusable umbilical single-port platform is a fascinating conceptual evolution of laparoscopic surgery with great potential application in urology [1]. The enormous pressure to reduce costs experienced by hospitals has restricted the use of expensive single-use products and facilitated the development of home-made devices, but still based on disposable components [7,22,23].
Because of its completely reusable nature, KeyPort is a precise cost-effective system with evident economic advantages. The cost of inventory material is equivalent to that of conventional laparoscopy and the durability of the equipment has been confirmed by the present group. Surgery with disposable ports adds an extra cost of e180 per case for four-port laparoscopy and e210–550 per case for LESS (depending on the single-port disposable platform used). KeyPort is sold in components: unlimited use rigid plastic trocar and obturator (e240), and a silicone cap that can be reused 20 times (e150). This means that the extra cost for a case with this new platform compared with conventional laparoscopy with reusable ports stands at about e10. However, compared with conventional laparoscopy or LESS with disposable material the saving is e170 and e200–540 per case, respectively.
Table II. Outcomes of umbilical laparoendoscopic pelvic surgery. Procedure Radical prostatectomy No. of cases
66
Age (years)
64.2 ± 5.1
BMI (kg/m2)
29.6 ± 3.7
OT (min)
195 ± 49
EBL (ml) Hb difference (g/dl)
Radical cystectomy 10
Diverticulectomy
Bilateral orchiectomy
Ureteral reimplantation
1
1
1
78
22
78
26.9 ± 4.0
31.2
20.1
23.2
372 ± 65
180
65
140
269 ± 94
343 ± 85
300
50
100
2.9 ± 1.2
2.47 ± 1.1
4.1
0.2
1.1
72 ± 11.9
Transfusion rate (%)
4.5
40
0
0
0
Hospital stay (days)
3.6 ± 3.6
10.7 ± 4.7
3
1
2
VAPS
1.9 ± 0.8
3.5 ± 0.5
2
0
1
VAWSS
9.3 ± 0.8
8.4 ± 0.8
10
10
10
Data are shown as mean ± SD. BMI = body mass index; OT = operative time; EBL = estimated blood loss; Hb = haemoglobin; VAPS = visual analogue pain scale; VAWSS = visual analogue wound satisfaction scale.
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Table III. Results after surgery: pathology and early postoperative complications. Pelvic procedures Radical prostatectomy n = 66 (9 pT2a, 3 pT2b, 41 pT2c, 11 pT3a, 2 pT3b)
No complications (n = 55) Grade I (n = 3): vomiting; urine leakage; rectal lesion primarily repaired Grade II (n = 5): atrial fibrillation managed with beta-blockers; unilateral orchitis; transfusion; ileus requiring parenteral nutrition; urine leakage and bleeding needing transfusion Grade IIIa (n = 1): deep venous thrombosis, bleeding requiring transfusion and cava filter Grade IIIb (n = 1): delayed rectal lesion with peritonitis requiring colostomy
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Grade IVa (n = 1): hypercapnia with respiratory acidosis (ICU stay) Radical cystectomy n = 10 (4 pT2, 3 pT3a, 2 pT3b, 1 pT4)
No complications (n = 5) Grade II (n = 3): transfusion (n = 2); ileus requiring parenteral nutrition (n = 1) Grade IIIb (n = 1): rectal lesion and faecal peritonitis Grade IVb (n = 1): septic shock, transfusion and ICU stay
Other techniques n = 3 (all benign)
No complications (n = 3)
Renal procedures Radical nephrectomy n = 7 (2 pT1a, 1 pT1b, 1 pT2a, 2 pT3a, 1 benign)
No complications (n = 4) Grade I (n = 1): ileus Grade II (n = 2): uncontrolled diabetes; transfusion
Partial nephrectomy n = 6 (2 pT1a, 4 benign)
No complications (n = 3) Grade I (n = 1): caecal dilatation (Ogilvie’s syndrome) Grade II (n = 1): pulmonary embolism Grade IVa (n = 1): difficult extubation and ICU stay
Nephroureterectomy n = 5 (1 pTa, 2 pT1, 1 pT2, 1 pT3)
No complications (n = 3) Grade I (n = 1): ileus Grade II (n = 1): transfusion
Other techniques n = 3 (all benign)
No complications (n = 3)
ICU = intensive care unit.
Another advantage of the KeyPort system is that the integrated design of the trocar and double-bend instruments allows the widest range of movement and unimpaired visualization. Additional use of a mini-laparoscopy port is a perfect complement as it provides a wider working angle, easier performance of complicated steps of surgery, and consolidation of the surgeon and assistant duo; all without cosmetic impact and still minimizing damage to the abdominal wall. In fact, the authors have recently described the combination of this system placed in the umbilicus and mini-laparoscopic material to effectively perform urological ablative procedures with organ retrieval, leaving no residual scar and
maximizing the safety of both patient and surgeon [11,13]. Surgeries that require smaller incisions for specimen extraction appear to be the best indications for the umbilical approach, and concern about cosmetics is probably higher in patients with non-lifethreatening diseases [24,25]. The benefits of LESS for urological surgery currently under study are postoperative pain reduction, decreased analgesic use and shortened convalescence [18,19,24–26]. In addition, adapting to the single port requires the performance of more meticulous and careful surgery, which could imply less blood loss and decreased hospital stay. Obvious disadvantages are increased
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Umbilical urological surgery operating time and difficulty. Complications are more likely to be related to the technique itself than to the approach [27]. Higher ASA score and malignant disease at pathology have been recognized as risk factors for complications [27]. Taking into account that the casuistry treated were consecutive non-selected patients with a predominance of malignant conditions and high BMI, and that this was a rather elderly population, it is not surprising that a substantial proportion presented with minor complications that were managed conservatively. Major complications occurred at a rate of 1 in 16.7 and in half of these were solved before discharge. Therefore, it may be concluded that umbilical surgery using the KeyPort is feasible and safe for a wide variety of urological procedures in non-selected patients, with very low postoperative pain and excellent patient satisfaction with the wound. Few reported single-centre experiences have reached or surpassed 100 cases [4,5,7], but what is new in this series is that it did not follow restrictive criteria to indicate surgery (low BMI or absence of prior abdominal surgery), as has been recommended by the Endourological Society NOTES and LESS Working Group and European Society of Urotechnology NOTES and LESS Working Group [28]. The present experience is also peculiar because of the extended execution of pelvic surgery and treatment of malignant disease. It is therefore possible that the rate with which an accessory port was used may be substantially higher than in other series based mainly on upper urinary tract surgery [4,5,7]. All procedures were completed in an acceptable time-frame without conversion to open surgery or conventional multitrocar laparoscopy, with good operative parameters and a very low intraoperative transfusion rate. The operative outcomes reported here are comparable to other large series from academic institutions with consolidated experience in LESS or robotic LESS [2,4,5,7,15,22,23] and in terms of security this experience is also within the range of multi-institutional reports [27,29]. However, some limitations from this experience must be recognized. First, although no cancer-related events presented, the duration of follow-up is insufficient to properly evaluate oncological outcomes. Secondly, this study does not allow comparison between umbilical urological surgery and conventional laparoscopy and, although trauma to the abdominal wall is minimized and cosmetic results were improved, the real advantages of umbilical KeyPort surgery in this field remain to be proven. Patientperceived benefits other than cosmetic appearance would be desirable to promote umbilical urological surgery on a large scale [30]. Both longer follow-up of
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the series and randomized controlled trials are needed to overcome these limitations. Finally, concise costeffective analysis should be conducted before wide adoption of the umbilical approach, although reusable materials seem to have clear advantages over disposable devices. In conclusion, umbilical laparoendoscopic urological surgery using KeyPort and DuoRotate instruments alone or in combination with mini-laparoscopy material in a reduced port approach is technically feasible, effective and safe for a great variety of urological procedures, both ablative and reconstructive. This approach offers adequate satisfactory operative parameters, scarce postoperative pain, excellent cosmetic results and very high satisfaction with the wound. The favourable experience reported here should be consolidated by more robust studies with longer follow-up that evaluate the oncological results properly. Prospective comparison with standard laparoscopy should also be conducted to promote its widespread use. The significantly reduced cost associated with reusable materials may contribute to further adoption of umbilical surgery in urological practice.
Acknowledgements The authors thank Mr Jesús Arconada and Mr Juan Manuel Gómez (Grupo Taper, Madrid), Mr Stefan Gillé, Mr Benjamin Seidenspinner and Mr Juergen Steinbeck (Richard Wolf GmbH, Knittlingen) for providing instrumental support, and Mr José Domínguez for photographic assistance. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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[18] Cáceres F, Cabrera PM, Mateo E, Andrés G, Lista F, García-Tello A, et al. Onset of a training program for singleport laparoscopic Urology. Actas Urol Esp 2012;36:418–24. [19] Tugcu V, Ilbey YO, Mutlu B, Tasci AI. Laparoendoscopic single-site surgery versus standard laparoscopic simple nephrectomy: a prospective randomized study. J Endourol 2010;24:1315–20. [20] Desai MM, Stein R, Rao P, Canes D, Aron M, Rao PP, et al. Embryonic natural orifice transumbilical endoscopic surgery (E-NOTES) for advanced reconstruction: initial experience. Urology 2009;73:182–7. [21] Stolzenburg JU, Do M, Haefner T, Dietel A, Kallidonis P, Kyriazis I, et al. Laparoendoscopic single-site surgery radical nephrectomy. J Endourol 2011;25:159–65. [22] Jeon HG, Jeong W, Oh CK, Lorenzo EI, Ham WS, Rha KH, et al. Initial experience with 50 laparoendoscopic single site surgeries using a homemade, single port device at a single center. J Urol 2010;183:1866–72. [23] Pak C-H, Baik S, Kim CS. Initial experience with retroperitoneal laparoendoscopic single-site surgery for upper urinary tract surgery. Korean J Urol 2011;52:842–6. [24] Jeong BC, Park YH, Han DH, Kim HH. Laparoendoscopic single-site and conventional laparoscopic adrenalectomy: a matched case–control study. J Endourol 2009;23: 1957–60. [25] He Y, Li NN, Chen Z, Luo YC, Chen X. Retroperitoneal laparoendoscopic single-site ureterolithotomy for upper ureteral stone disease. Scand J Urol 2013;47:515–20. [26] Canes D, Berger A, Aron M, Brandina R, Goldfarb DA, Shoskes D, et al. Laparo-endoscopic single site (LESS) versus standard laparoscopic left donor nephrectomy: matched-pair comparison. Eur Urol 2010;57:95–101. [27] Greco F, Cindolo L, Autorino R, Micali S, Stein RJ, Bianchi G, et al. Laparoendoscopic single-site upper urinary tract surgery: assessment of postoperative complications and analysis of risk factors. Eur Urol 2012;61: 510–16. [28] Gettman MT, White WM, Aron M, Autorino R, Averch T, Box G, et al. Where do we stand with LESS and NOTES? Eur Urol 2011;59:231–4. [29] Autorino R, Kaok JH, Yakoubi R, Rha KH, Stein RJ, White WM, et al. Urological laparoendoscopic single site surgery: multi-institutional analysis of risk factors for conversion and postoperative complications. J Urol 2012;187: 1989–94. [30] Olweny EO, Mir SA, Best SL, Park SK, Donnally CIII, Cadeddu JA, et al. Importance of cosmesis to patients undergoing renal surgery: a comparison of laparoendoscopic single-site (LESS), laparoscopic and open surgery. BJU Int 2012;110:268–72.
ORIGINAL ARTICLE
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Umbilical laparoendoscopic urological surgery with a novel reusable device
ANA GARCÍA-TELLO, PEDRO M. CABRERA, FELIPE CÁCERES, FERNANDO RAMÓN DE FATA, ERIKA MATEO & JAVIER C. ANGULO Department of Urology, Hospital Universitario de Getafe, Fundación para la Investigación Biomédica, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Madrid, Spain
Abstract Objective.The aims of this study were to present cumulative experience with umbilical laparoendoscopic urological surgery using a reusable device and to evaluate outcomes and complications in the first 100 patients. Material and methods. Patients undergoing umbilical surgery with the KeyPort system and DuoRotate instruments (Richard Wolf, Knittlingen, Germany) were evaluated prospectively. Demographic, intraoperative and postoperative data were assessed. Results.Between October 2011 and July 2012, 79 pelvic (66 radical prostatectomy, 10 radical cystectomy, one diverticulectomy, one bilateral orchiectomy, one ureter reimplantation) and 21 renal (seven radical nephrectomy, six partial nephrectomy, five nephroureterectomy, two pyeloplasty, one pyelolithotomy) surgeries were performed through the umbilicus using this platform. Followup was 56.7 ± 12.6 weeks (mean ± SD). Mean age was 64.3 ± 10.3 years, body mass index 29 ± 4.6 kg/m2, operative time 232 ± 106 min and estimated blood loss 260 ± 95 ml. Conversion to standard multiport laparoscopy was not necessary. An accessory port was used in 87 cases to facilitate suturing and conduct drainage extraction. Postoperative complications occurred in 24 cases (six Clavien grade I, 12 grade II, one grade IIIa, two grade IIIb, two grade IVa, one grade IVb). Mean hospital stay was 4.2 ± 4 days. Total transfusion rate was 10%. Mean visual analogue pain scale at day 2 was 2.1 ± 1.3 (0–10). Visual analogue wound satisfaction scale at month 1 was 9.2 ± 0.6 (0–10). No cancer-related events occurred during follow-up. Late complications (4%) were not related to the surgical approach. Conclusions.Umbilical KeyPort surgery is technically feasible for a great variety of procedures, both ablative and reconstructive. This access offers adequate surgical outcomes, scarce postoperative pain and security for the patient in the short term. Its reusable nature implies a noticeable economic advantage.
Key Words: complications, LESS, outcomes, umbilicus, urological surgery
Introduction Increased experience in laparoscopic surgery has led surgeons to direct their efforts towards improving safety for the patient, minimizing discomfort and shortening convalescence. Laparoendoscopic singlesite (LESS) surgery has developed as an evolution of minimally invasive surgery that brings the latest advantages in enhanced cosmetics and decreased pain compared with conventional laparoscopy with multiple trocars and specifically with regard to extraction of the specimen [1]. Multichannel single-access
ports and novel bent instruments allow surgery to be carried out through a single skin incision that can be hidden within the umbilicus; therefore, using this embryonic natural orifice gives the maximum aesthetic benefit and respect for the integrity of the abdominal wall [2]. Only a few years after Raman et al. published the first account of urological LESS surgery [3], this technique has become widely applied in different settings and for many different urological procedures [4–7]. Researchers have reported the feasibility and shortterm outcomes in their series; however, questions
Correspondence: J. C. Angulo, Hospital Universitario de Getafe, Carretera de Toledo Km 12,500, 28905 Madrid, Spain. Tel: +34 916247306. Fax: +34 916247309. E-mail: [email protected]
(Received 24 July 2013; revised 12 November 2013; accepted 4 December 2013) ISSN 2168-1805 print/ISSN 2168-1813 online 2014 Informa Healthcare DOI: 10.3109/21681805.2013.876096
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remain regarding both the potentially long learning curve and the comparative benefit in experienced hands between this technique and conventional or robot-assisted laparoscopy [8]. New technical developments, including robotic applications and more precise manual systems, are contributing to further promotion of the field [1,2,9], and the reusable nature of some of these platforms constitutes an economic advantage. The addition of mini-laparoscopy instruments through an accessory port facilitates surgery without a cosmetic impact as the residual scar of this orifice becomes invisible. The present authors have previously reported their initial developmental experience with this system in different urological procedures [10–13]. This article describes cumulative data regarding the first 100 patients undergoing umbilical surgery with a reduced port approach for both ablative and reconstructive procedures in this institution. Material and methods Study population A prospective observational study was performed in a university hospital to evaluate the feasibility and safety of different urological procedures using a reusable laparoendoscopic system placed in the umbilicus, in consecutive non-selected patients with an indication
for transperitoneal laparoscopic urological surgery who consented to this approach. All patients were operated on by the same surgical team (PMC and FC). The only exclusion criterion for this approach was that the patient preferred conventional multiport laparoscopy or open surgery. Previous abdominal surgery or radiation was not considered a contraindication for the technique. Operative results, outcomes and complications were evaluated. Patients’ data were entered in an institutional reviewed boardapproved database that included demographics, gender, patient age and body mass index (BMI).
Surgical technique The procedures were performed with a reusable KeyPort system placed inside the umbilicus, with the patient in the flank position for renal surgery and in the Trendelenburg position for pelvic procedures. A reusable rigid trocar is inserted in a screw-driven fashion through a 2.5 cm umbilical opening without the need for fixation or gas leakage (Figure 1). After removal of the inner element, the soft multichannel silicone seal cover with three openings (5, 10 and 15 mm) is closed to insert curved instruments with the DuoRotate system that allows precise 360 movement of the tip. A right-handed surgeon uses atraumatic prehension forceps with the left hand and
Figure 1. KeyPort fitting a 2.5 cm umbilical incision with instruments and lens inserted.
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Umbilical urological surgery Metzenbaum scissors with the right. The assistant holds the camera on a 5.7 mm wide, 50 cm long, 0 or 30 Panoview lens. Straight instruments, such as specific suction irrigation or Eragon forceps, can be combined. All the aforementioned elements are produced by Richard Wolf (Knittlingen, Germany). Additional instrumentation includes the ForceTriad electrosurgical device (5 or 10 mm; Covidien, Dublin, Ireland), Hem-o-lok (Teleflex, Research Triangle Park, NC, USA) clip applier and Endopouch Retriever (Johnson & Johnson, New Brunswick, NJ, USA). Owing to the absence of a specific needle holder, an ancillary 3.5 mm reusable port is incorporated in the iliac fossa (for pelvic surgery) or hypochondrium (for renal surgery) for all procedures that require suture (Figure 2). At this time, the surgeon holds the minilaparoscopy needle holder with the right hand and the DuoRotate forceps in the KeyPort on the left, while the assistant holds the camera and suction irrigation pump, also through the KeyPort. The accessory port is also used to insert the suction irrigation device and at the end of the procedure for drainage extraction. For radical cystectomy a 10 mm extra-port placed in the right iliac fossa is used to insert the suction irrigation system, perform urethral anastomosis in orthotopic reservoirs and extract drainage and bilateral ureteral stents. In no case were two or more extra ports needed. Manoeuvres to avoid additional port placement
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included marionette sutures coming out through the skin to retract hollow organs such as the bladder or colon, or very occasionally direct insertion of needlescopic instruments for liver or kidney retraction. Only rarely was it necessary to increase wound size to remove the surgical specimen and in those cases only the aponeurosis and not the skin was incised. Analysis Operative data recorded were estimated blood loss (EBL) in the operating room, haemoglobin difference calculated as postoperative day 2 minus preoperative day –14, time of surgery, conversion to standard laparoscopy, intraoperative transfusion rate and intraoperative complications. Postoperative transfusion rate, hospital stay, immediate postoperative adverse events and visual analogue pain scale (VAPS) scores at day 2 were also obtained. Patients were followed after discharge for evidence of remote adverse events and to receive the histological report. Patient satisfaction at 3–4 weeks was assessed on a visual analogue wound satisfaction scale (VAWSS), from 0 to 10, by the same doctor in the office. This scale was provided by showing the patient sketches of three different incisions (open incision in the form of lumbar or midline infraumbilical incision, laparoscopy with five ports and umbilical surgery with one additional port) through which surgery could have
Figure 2. Umbilical KeyPort and 3.5 mm reusable mini-laparoscopy port placed on the right iliac fossa.
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been performed, then immediately asking the patient to rate his or her own incision in terms of satisfaction with the wound [11,13]. Patients were also specifically followed for evidence of local umbilical adverse events and regarding cosmetic aspects of the wound at month 3. Surgical complications were classified according to the Clavien–Dindo scheme [14]. At the time of this report all cases had been contacted by telephone by the same doctor (AG) to rule out late events.
Results Between October 2011 and July 2012, 100 umbilical urological procedures using the KeyPort system were performed in the authors’ institution by two surgeons experienced in laparoscopic procedures (PMC and FC). They included 79 pelvic procedures (prostatectomy, n = 66; radical cystectomy, n = 10; diverticulectomy, n = 1; bilateral orchiectomy for androgen insensitivity syndrome, n = 1; ureteral reimplantation, n = 1) and 21 renal surgeries (radical nephrectomy, n = 7; partial nephrectomy, n = 6; nephroureterectomy, n = 5; pyeloplasty, n = 2; pyelolithotomy, n = 1). One accessory port was used in 87 cases (3.5 mm in 77 and 10 mm in 10), incorporated to ease intracorporeal suturing and facilitate drainage extraction in 78 out of 79 pelvic (98.7%) and nine out of 21 renal surgeries (42.9%). Procedures in which no suture was needed were driven through the KeyPort platform exclusively placed in the umbilicus through a 2.5 cm incision. Marionette sutures were used in 78 cases and direct insertion of needlescopic instruments in two. The bladder cuff during nephroureterectomy was performed through partial cystectomy and bladder closure. Nephron-sparing surgery used a clampless technique in four out of six cases. Orthotopic urinary diversion was performed in six out of 10 cases after radical cystectomy and ileal conduit in the rest. Ileoileal anastomosis and diversion was performed extracorporeally and the neobladder was reintroduced and laparoendoscopically anastomosed to the urethra. Surgery was successfully completed in all cases, without the need for conversion to standard multiport laparoscopy or open surgery. During the same period, 51 patients chose conventional multiport laparoscopy and 28 open procedures in this institution. The male to female ratio was 7.3:1 (male, n = 88; female, n = 12). For the entire cohort, the mean ± SD age was 64.3 ± 10.3 years and mean BMI 29 ± 4.6 kg/m2. The American Society of Anesthesiologists (ASA) score was I in 11%, II in 68%, III in 20% and IV
in 1%. Prior abdominal surgery had been performed in 17% of patients. The indication for surgery was oncological in 90 patients, reconstructive in five and ablative non-oncological in five. Mean operative time was 232 ± 106 min, EBL 260 ± 95 ml and haemoglobin difference 2.8 ± 1.3 g/dl. No intraoperative complications occurred and the intraoperative transfusion rate was 2% (radical cystectomy, n = 1; partial nephrectomy, n = 1). Mean hospital stay was 4.2 ± 4 days. There was no statistically significant difference in hospital stay between renal (3.3 ± 1.3 days) and pelvic surgery (4.5 ± 4.4 days) (p = 0.9). The mean VAPS score at day 2 (on a scale from 0 to 10) was 2.1 ± 1.3. During the immediate postoperative period, surgical minor complications occurred in 18% and major complications (grade III or higher) in 6%. No grade V complications were observed. Major complications were not more common during the early experience and were distributed throughout the experience. The postoperative transfusion rate was 8%. No cancer-related events have occurred during follow-up. Patient satisfaction with the wound based on the VAWSS (from 0 to 10), investigated at 1 month, was 9.2 ± 0.6. Complete demographic and outcome data are shown in Tables I and II. Pathology and early complications (within 1 month) are shown in Table III. Mean follow-up was 56.7 ± 12.6 weeks (range 35–78 weeks) at the time of this report. Late complications within this follow-up occurred in 4% and included bladder neck stricture, acute pyelonephritis, chronic renal insufficiency and chronic pyelonephritis, and pseudoaneurysm with arteriovenous fistula (one case each). Discussion Several variations have emerged to ease the major difficulties encountered during single-site surgery. Robot-assisted LESS may reduce some of the limitations and make complicated reconstructive procedures feasible [2,6]. However, wide adoption of this alternative would require redesign or development of new robotic platforms. The use of minilaparoscopy is another variation that does not compromise the concept of “scarless” surgery and constitutes the natural evolution of laparoscopy [15,16]. Multichannel ports are now better designed to offer more flexibility and the use of bent instruments allows triangulation and reduced internal and external clashing [1]. However, this approach remains technically challenging and a solid laparoscopic background is desirable before performing umbilical surgery routinely [17]. Advantages over laparoscopic
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Umbilical urological surgery Table I. Outcomes of umbilical laparoendoscopic upper urinary tract surgery.
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Procedure Radical nephrectomy
Partial nephrectomy
Nephroureterectomy
Pyeloplasty
Pyelolithotomy
No. of cases
7
6
5
2
1
Age (years)
67.4 ± 16.4
59.1 ± 15.3
64.8 ± 12.4
BMI (kg/m2)
29.9 ± 8.3
29.8 ± 7.1
25.6 ± 4.6
53 ± 22.6
42
23.7 ± 2.3
31.6
OT (min)
189 ± 37
206 ± 52
238 ± 55
190 ± 71
240
EBL (ml)
300 ± 141
400 ± 155
290 ± 134
137 ± 88
50
Hb difference (g/dl)
2.5 ± 1.6
2.12 ± 1.6
3.3 ± 1.4
2±0
0.6
Transfusion rate (%)
14.3
16.7
20
0
0
Hospital stay (days)
2.8 ± 0.9
2.8 ± 0.7
3.8 ± 1.9
3±0
2
VAPS
2.7 ± 0.7
1.2 ± 0.9
2.2 ± 0.8
1.5 ± 0.7
2
VAWSS
8.4 ± 0.8
9.1 ± 0.8
8.4 ± 0.9
9.5 ± 0.7
9
Data are shown as mean ± SD. BMI = body mass index; OT = operative time; EBL = estimated blood loss; Hb = haemoglobin; VAPS = visual analogue pain scale; VAWSS = visual analogue wound satisfaction scale.
surgery in selected patients and by experienced surgeons include superior cosmesis, decreased pain and quicker recovery, with no increase in operative time in experienced hands [18,19]. Disadvantages include the limited range of movements and increased cost if disposable devices are used. Placement of an accessory port optimizes exposure of the operative field and facilitates difficult tasks in advanced reconstruction [20,21]. Scarless (masked scar) surgery using a reusable umbilical single-port platform is a fascinating conceptual evolution of laparoscopic surgery with great potential application in urology [1]. The enormous pressure to reduce costs experienced by hospitals has restricted the use of expensive single-use products and facilitated the development of home-made devices, but still based on disposable components [7,22,23].
Because of its completely reusable nature, KeyPort is a precise cost-effective system with evident economic advantages. The cost of inventory material is equivalent to that of conventional laparoscopy and the durability of the equipment has been confirmed by the present group. Surgery with disposable ports adds an extra cost of e180 per case for four-port laparoscopy and e210–550 per case for LESS (depending on the single-port disposable platform used). KeyPort is sold in components: unlimited use rigid plastic trocar and obturator (e240), and a silicone cap that can be reused 20 times (e150). This means that the extra cost for a case with this new platform compared with conventional laparoscopy with reusable ports stands at about e10. However, compared with conventional laparoscopy or LESS with disposable material the saving is e170 and e200–540 per case, respectively.
Table II. Outcomes of umbilical laparoendoscopic pelvic surgery. Procedure Radical prostatectomy No. of cases
66
Age (years)
64.2 ± 5.1
BMI (kg/m2)
29.6 ± 3.7
OT (min)
195 ± 49
EBL (ml) Hb difference (g/dl)
Radical cystectomy 10
Diverticulectomy
Bilateral orchiectomy
Ureteral reimplantation
1
1
1
78
22
78
26.9 ± 4.0
31.2
20.1
23.2
372 ± 65
180
65
140
269 ± 94
343 ± 85
300
50
100
2.9 ± 1.2
2.47 ± 1.1
4.1
0.2
1.1
72 ± 11.9
Transfusion rate (%)
4.5
40
0
0
0
Hospital stay (days)
3.6 ± 3.6
10.7 ± 4.7
3
1
2
VAPS
1.9 ± 0.8
3.5 ± 0.5
2
0
1
VAWSS
9.3 ± 0.8
8.4 ± 0.8
10
10
10
Data are shown as mean ± SD. BMI = body mass index; OT = operative time; EBL = estimated blood loss; Hb = haemoglobin; VAPS = visual analogue pain scale; VAWSS = visual analogue wound satisfaction scale.
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Table III. Results after surgery: pathology and early postoperative complications. Pelvic procedures Radical prostatectomy n = 66 (9 pT2a, 3 pT2b, 41 pT2c, 11 pT3a, 2 pT3b)
No complications (n = 55) Grade I (n = 3): vomiting; urine leakage; rectal lesion primarily repaired Grade II (n = 5): atrial fibrillation managed with beta-blockers; unilateral orchitis; transfusion; ileus requiring parenteral nutrition; urine leakage and bleeding needing transfusion Grade IIIa (n = 1): deep venous thrombosis, bleeding requiring transfusion and cava filter Grade IIIb (n = 1): delayed rectal lesion with peritonitis requiring colostomy
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Grade IVa (n = 1): hypercapnia with respiratory acidosis (ICU stay) Radical cystectomy n = 10 (4 pT2, 3 pT3a, 2 pT3b, 1 pT4)
No complications (n = 5) Grade II (n = 3): transfusion (n = 2); ileus requiring parenteral nutrition (n = 1) Grade IIIb (n = 1): rectal lesion and faecal peritonitis Grade IVb (n = 1): septic shock, transfusion and ICU stay
Other techniques n = 3 (all benign)
No complications (n = 3)
Renal procedures Radical nephrectomy n = 7 (2 pT1a, 1 pT1b, 1 pT2a, 2 pT3a, 1 benign)
No complications (n = 4) Grade I (n = 1): ileus Grade II (n = 2): uncontrolled diabetes; transfusion
Partial nephrectomy n = 6 (2 pT1a, 4 benign)
No complications (n = 3) Grade I (n = 1): caecal dilatation (Ogilvie’s syndrome) Grade II (n = 1): pulmonary embolism Grade IVa (n = 1): difficult extubation and ICU stay
Nephroureterectomy n = 5 (1 pTa, 2 pT1, 1 pT2, 1 pT3)
No complications (n = 3) Grade I (n = 1): ileus Grade II (n = 1): transfusion
Other techniques n = 3 (all benign)
No complications (n = 3)
ICU = intensive care unit.
Another advantage of the KeyPort system is that the integrated design of the trocar and double-bend instruments allows the widest range of movement and unimpaired visualization. Additional use of a mini-laparoscopy port is a perfect complement as it provides a wider working angle, easier performance of complicated steps of surgery, and consolidation of the surgeon and assistant duo; all without cosmetic impact and still minimizing damage to the abdominal wall. In fact, the authors have recently described the combination of this system placed in the umbilicus and mini-laparoscopic material to effectively perform urological ablative procedures with organ retrieval, leaving no residual scar and
maximizing the safety of both patient and surgeon [11,13]. Surgeries that require smaller incisions for specimen extraction appear to be the best indications for the umbilical approach, and concern about cosmetics is probably higher in patients with non-lifethreatening diseases [24,25]. The benefits of LESS for urological surgery currently under study are postoperative pain reduction, decreased analgesic use and shortened convalescence [18,19,24–26]. In addition, adapting to the single port requires the performance of more meticulous and careful surgery, which could imply less blood loss and decreased hospital stay. Obvious disadvantages are increased
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Umbilical urological surgery operating time and difficulty. Complications are more likely to be related to the technique itself than to the approach [27]. Higher ASA score and malignant disease at pathology have been recognized as risk factors for complications [27]. Taking into account that the casuistry treated were consecutive non-selected patients with a predominance of malignant conditions and high BMI, and that this was a rather elderly population, it is not surprising that a substantial proportion presented with minor complications that were managed conservatively. Major complications occurred at a rate of 1 in 16.7 and in half of these were solved before discharge. Therefore, it may be concluded that umbilical surgery using the KeyPort is feasible and safe for a wide variety of urological procedures in non-selected patients, with very low postoperative pain and excellent patient satisfaction with the wound. Few reported single-centre experiences have reached or surpassed 100 cases [4,5,7], but what is new in this series is that it did not follow restrictive criteria to indicate surgery (low BMI or absence of prior abdominal surgery), as has been recommended by the Endourological Society NOTES and LESS Working Group and European Society of Urotechnology NOTES and LESS Working Group [28]. The present experience is also peculiar because of the extended execution of pelvic surgery and treatment of malignant disease. It is therefore possible that the rate with which an accessory port was used may be substantially higher than in other series based mainly on upper urinary tract surgery [4,5,7]. All procedures were completed in an acceptable time-frame without conversion to open surgery or conventional multitrocar laparoscopy, with good operative parameters and a very low intraoperative transfusion rate. The operative outcomes reported here are comparable to other large series from academic institutions with consolidated experience in LESS or robotic LESS [2,4,5,7,15,22,23] and in terms of security this experience is also within the range of multi-institutional reports [27,29]. However, some limitations from this experience must be recognized. First, although no cancer-related events presented, the duration of follow-up is insufficient to properly evaluate oncological outcomes. Secondly, this study does not allow comparison between umbilical urological surgery and conventional laparoscopy and, although trauma to the abdominal wall is minimized and cosmetic results were improved, the real advantages of umbilical KeyPort surgery in this field remain to be proven. Patientperceived benefits other than cosmetic appearance would be desirable to promote umbilical urological surgery on a large scale [30]. Both longer follow-up of
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the series and randomized controlled trials are needed to overcome these limitations. Finally, concise costeffective analysis should be conducted before wide adoption of the umbilical approach, although reusable materials seem to have clear advantages over disposable devices. In conclusion, umbilical laparoendoscopic urological surgery using KeyPort and DuoRotate instruments alone or in combination with mini-laparoscopy material in a reduced port approach is technically feasible, effective and safe for a great variety of urological procedures, both ablative and reconstructive. This approach offers adequate satisfactory operative parameters, scarce postoperative pain, excellent cosmetic results and very high satisfaction with the wound. The favourable experience reported here should be consolidated by more robust studies with longer follow-up that evaluate the oncological results properly. Prospective comparison with standard laparoscopy should also be conducted to promote its widespread use. The significantly reduced cost associated with reusable materials may contribute to further adoption of umbilical surgery in urological practice.
Acknowledgements The authors thank Mr Jesús Arconada and Mr Juan Manuel Gómez (Grupo Taper, Madrid), Mr Stefan Gillé, Mr Benjamin Seidenspinner and Mr Juergen Steinbeck (Richard Wolf GmbH, Knittlingen) for providing instrumental support, and Mr José Domínguez for photographic assistance. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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