Minimally Invasive Therapy. 2014;23:214–222

ORIGINAL ARTICLE

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

The short-term outcomes of conventional and single-port laparoscopic surgery for rectal cancer: A comparative non-randomized study

KATARINA LEVIC & ORHAN BULUT Department of Surgical Gastroenterology, Copenhagen University Hospital Hvidovre, University of Copenhagen, Copenhagen, Denmark

Abstract Background: Single-port laparoscopic surgery (SPLS) has evolved as an alternative method to conventional laparoscopic surgery (CLS). The aim of this study is to evaluate the results of SPLS compared to CLS in the treatment of rectal cancer. Material and methods: Prospectively collected data of patients who had undergone either CLS (n = 194) or SPLS (n = 36) for rectal cancer in the period between 2009 and 2012 were retrospectively analyzed. Results: Median operative time was higher in patients with SPLS (p = 0.01), but the median operative blood loss was significantly lower (p = 0.006). No significant difference was found in intraoperative- (p = 0.14) or postoperative complication rate (p = 0.4) or 30-day mortality (p = 0.62). A tendency towards fewer late complications in the SPLS-group was seen (11.1% vs. 25.3%), but the difference was not significant (p = 0.084). Conclusion: SPLS for rectal cancer is a safe method in a selected group of patients. Further studies are needed to confirm the benefits of SPLS. Operative time is longer, but the intraoperative blood loss is reduced.

Key words: Rectal cancer, single-incision laparoscopic surgery, single-port, colorectal surgery

Introduction The emergence of laparoscopy constitutes one of the most essential paradigm shifts in the practice of surgery, with conventional laparoscopic surgery (CLS) being the treatment of choice for many procedures. The benefits of CLS include reduced morbidity, less post-operative pain, faster recovery and reduced blood loss. In addition, CLS has shown similar oncological outcomes as compared to open colorectal cancer surgery (1,2). Despite the advantages of CLS, new minimally invasive techniques are being developed, as every incision carries risks of bleeding, infection, damage to visceral organs and formation of incisional hernia. To reduce the surgical trauma, morbidity and improve cosmetic outcome, new minimally invasive procedures such as natural orifice transluminal endoscopic surgery (NOTES) and single-port laparoscopic surgery (SPLS) have evolved as alternative methods to

conventional laparoscopic surgery. SPLS is already used in several procedures including colectomy (3,4). However, the literature regarding SPLS for rectal cancer is limited and the benefits of SPLS over CLS in rectal surgery still need to be assessed (5– 8). To date no comparative study has addressed the role of SPLS in rectal cancer. The aim of this study is to evaluate the early results of SPLS compared to CLS in the treatment of rectal cancer.

Material and methods Between January 2009 and October 2012, laparoscopic surgery for the treatment of rectal cancer was performed in 230 patients at our institution. Of these, 194 patients (84.3%) were operated with conventional laparoscopic surgery (CLS) and 36 patients (15.7%) with single-port laparoscopic surgery

Correspondence: O. Bulut, Department of Surgical Gastroenterology, Copenhagen University Hospital Hvidovre, University of Copenhagen, Kettegaards Allé 30, DK-2650 Hvidovre, Copenhagen, Denmark. Fax: +45 38622760. E-mail: [email protected] ISSN 1364-5706 print/ISSN 1365-2931 online  2014 Informa Healthcare DOI: 10.3109/13645706.2014.885909

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

Short-term outcomes of conventional and single-port laparoscopic surgery for rectal cancer (SPLS). None of the patients operated during this period were excluded from this study. Tumour staging and preoperative assessment consisted of digital rectal examination, proctoscopy, pathological examination, abdominal ultrasound, thoracoabdominal computerized tomography (CT) scans and pelvic magnetic resonance imaging (MRI), in accordance with the guidelines of the Danish Colorectal Cancer Group (DCCG) (9). All patients were discussed at the multidisciplinary team (MDT) conference prior to the decision of treatment. The selection criteria for the SPLS technique are shown in Table I. All procedures followed the principle of total mesorectal excision (TME). All SPLS were carried out by the same surgical team. Depending on the location of the tumour, a SILS (Coviden, Norwalk, CT, USA) port was placed in a right or left quadrant possible stoma site or umbilical site. An open skin and fascial incision of 2.5 cm was used to access the abdominal cavity. The abdomen was entered under direct vision and the SILS (Covidien, Norwalk, Connecticut, USA) port was placed. The abdomen was insufflated with CO2 to a pressure of 12 mmHg. A 5 mm straight laparoscope with a 0 optic was used to image the abdominal cavity. A 5 mm Harmonic ACE (Ethicon Endo-Surgery, Puerto Rico USA) and a 5 mm curved endoscopic grasper were introduced via two other 5 mm ports. The position of the SILS device differs depending on tumor location and anatomical shape of the patients. The umblical site was used in particularly slim patients with upper rectal cancers and we preferred the right side placement in patients with mid rectal cancers because these patients would have a risk of protective loop ileostomy if their reconstructive anastomosis was 4 cm on MRI Local invasion on MRI and T4 obstructive cancers Tumor infiltration on adjacent organs on CT or MRI ASA-score >4–5 Previous major abdominal surgery Anticipated need of intensive care unit BMI >32 kg/m2 CT = computerized tomography; MRI = magnetic resonance imaging; ASA = American Society of Anesthesiologists; BMI = Body Mass Index.

215

all patients operated with transumblical access and/or chosen stoma site in the right side of abdomen. The surgeon stood on the left side of the patient when the chosen stoma and extraction site was located in the left lower quadrant. The patient was then placed in steep Trendenlenburg position and the operating table was rotated towards the right side. Subsequently the sigmoid colon was suspended towards the abdominal wall with transparietal sutures through the mesentery. Mesocolic dissection and inferior mesenteric pedicle isolation were achieved with medial approach and the superior rectal artery was divided just below the inferior mesenteric artery. The left ureter was then recognized and subsequently, with the patient placed supine and rotated left side up, medial-to-lateral dissection was continued cranially up until the left colon was mobilised. The patient was returned to the Trendelenburg position, and the small bowel was reflected cranially after the completion of mobilisation of the left colon. The grasper and previously inserted transabdominal sutures were used to elevate the rectosigmoid colon out of the pelvis and away from the retroperitoneum and sacral promontory, to enable entry into the presacral space. The posterior aspect of the mesorectum was easily identified and the mesorectal plane dissected with an ultrasonic scalpel, preserving the hypogastric nerves. Dissection was continued down to the presacral space in this avascular plane toward the pelvic floor. Elevation of the upper rectum by transabdominal sutures facilitated further posterior dissection along the back of the mesorectum to the pelvic floor. The anterior dissection between the rectum and the posterior vaginal wall (in females) and the seminal vesicles and prostate (in men) was performed by decreasing tension of the transabdominal sutures and retracting the peritoneal fold anterior to the rectum. Dissection proceeded laterally on both sides of the rectum until circumferential mobilisation of the lower rectum was accomplished. Digital examination was performed to verify the distance between the inferior margin of the tumour and the line of resection and the adequacy of the distal margin was marked with a clip. One 5 mm port was exchanged with a10 mm port. A blue EndoGIA roticulator stapler (Covidien Ltd., Norwalk, CT, USA) 45-mm was fired twice from this port to safely divide the lower rectum. The abdomen was then deflated and a wound protector (Alexis O, Applied Medical, Rancho Santo Margarita, CA, USA) was placed at the aperture of the SILS port. The specimen was extracted through the SILS aperture and resected. Extracorporal preparation of the proximal colon was completed with placement of the anvil of a circular stapler in position to perform a sideto-end or end-to-end colorectal anastomosis. After

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

216

K. Levic & O. Bulut

pneumoperitoneum reestablishment, a conventional intracorporeal colorectal anastomosis was made with transanal insertion of a circular stapler (Proximate ILS circular stapler, Ethicon, Endo-Surgery, Puerto Rico, USA) under direct vision. Testing for anastomosis was performed by insufflating air into the rectum while having the pelvic cavity filled with water. The fascia was closed with PDS sutures continuously and the skin was closed with interrupted 3/0 nylon sutures. In the cases needing a proximal diverting ileostomy, the diversion loop ilostomy was brought out through the SILS aperture approximately 20 cm proximal to the ileocoecal valve. The ileostomy was created in Turnbull fashion using 3/0 vicryl sutures. No drains were used. Intraabdominal smoke formation was drained via the insertion of an intravenous cannula working as a separate venting channel at the suprapubic site. The surgical techniques for both CLS and SPLS have been described in detail by the authors in a previous publication (10,11). Data were collected from a prospective database and results between patients operated with CLS and SPLS were compared. The data included patients and tumour characteristics, perioperative data, histopathological assessment, postoperative morbidity and mortality, length of hospital stay and follow-up. Anastomotic leaks were defined as any dehiscence of the anastomosis observed by endoscopy, digital examination, CT-scan or gastrograffin enema. All patients were followed up according to the guidelines of the Danish Colorectal Cancer Group (DCCG) (9) with digital rectal examination, proctosigmoideoscopy, colonoscopy and thoracoabdominal CT scans. Colonoscopy was carried out three months after the operation (clean colon) and then every five years until the age of 75. Thoracoabdominal CT scan was performed at one and three years postoperatively.

Statistical analysis The data collected were stored and analyzed using the statistical package IBM SPSS Statistics version 20.0 for Windows. Data are presented as median and percentages. Chi-square and Fisher’s exact test were used for categorical variables and Mann Whitney U-test for continuous variables. A p-value of < 0.05 was considered statistically significant.

Results Patient and tumour characteristics are shown in Table II. The patients in the two groups compared were similar. There was no difference in the median age or

co-morbidity (ASA-score). However, patients in the SPLS-group had significantly lower BMI-scores (p = 0.002). Fifty of the 194 patients (25.8%) operated with conventional laparoscopic surgery, and 13 of the 36 patients operated with single port access, had previously undergone an operative procedure in the abdomen (p = 0.22).

Surgical outcomes The median operative time was longer in patients with SPLS, with a median time of 295 minutes (range 108– 465) versus 248 minutes (51–431) in the CLS-group (p = 0.01), but the median operative blood loss (EBL) was significantly lower (35 ml vs. 100 ml; p = 0.006). Conversion to laparotomy was required in 13 patients (6.7%) in the CLS-group, due to fixation of tumour (n = 9), major bleeding (n = 1), adhesions (n = 1), severe intraabdominal obesity (n = 1) and intolerance to pneumoperitoneum (n = 1). In the SPLS group, no conversion to open surgery was necessary. Five procedures (13.9%) required placement of additional trocars: One procedure required conversion to laparoscopic surgery, three procedures required insertion of an extra port, due to fixation of tumour and severe pelvic fibrosis, and one to hand-assisted laparoscopic surgery. There were no intraoperative complications in patients operated with SPLS, while the rate of intraoperative complications in the CLS-group was 7.2% (14 patients) (Table III). The difference was however not significant (p = 0.14). The intraoperative complications that occurred in the CLS-group included perforation of a major blood vessel (n = 2), perforation of the bladder (n = 5), tumour perforation (n = 1), lesion of the ureter (n = 3), perforation of the anal canal (n = 1) and lesion of the rectum requiring suturing (n = 2). Only one of the 14 above mentioned intraoperative complications required conversion to laparatomy; it was a perforation of the internal iliac vein with the total intraoperative blood loss of 3142 mL. The remaining 13 intraoperative complications could be managed laparoscopically. The postoperative complication rate was 41.2% in the CLS-group and 27.8% in the SPLS-group (p = 0.14) (Table III). In the postoperative period we registered a total of 22 cases with anastomotic leaks in accordance with our previously mentioned criteria among the patients who underwent reconstructive surgery with CLS. Amongst those, 12 patients (6.1% [95% CI: 2.8–9.6]) required reoperation. The remaining ten patients were treated conservatively or with endoscopic vacuum assisted closure. Two patients in the SPLS group had

Short-term outcomes of conventional and single-port laparoscopic surgery for rectal cancer

217

Table II. Patient and tumour characteristics. CLS No. of patients (%) Median age, years (range) Gender (M/F) Median BMI, kg/m2 (range)

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

Median ASA-score

194 (84.3) 68 (30–88)

SPLS 36 (15.7) 69 (49–87)

0.021b

25 (15–40)

23.8 (16–32)

0.002a

2 (1–3)

2 (1–3)

0.78b

46 (23.7)

9 (25)

ASA 2, n (%)

110 (56.7)

22 (61.1)

ASA 3, n (%)

38 (19.6)

5 (13.9)

10 (0–15)

8 (2–15)

£5 cm, n (%)

41 (21.1)

12 (33.3)

6–10 cm, n (%)

85 (43.8)

12 (33.3)

68 (35.1)

12 (33.3)

50 (25.8) [20–32]

13 (36.1) [20–53]

‡11 cm, n (%) Previous abdominal surgery, n (%), [95 % CI]

0.37a

17/19

133/61

ASA 1, n (%)

Median tumour distance from anal verge, cm (range)

p-values

0.53a

0.22b

BMI = body mass index (kg/m2); ASA = American Society of Anesthesiologists score. a Mann-Whitney test. b Fisher’s exact test.

anastomotic leaks that required reoperation (5.6% (95% CI: 0–13%)). There was no difference in the total number of anastomotic leakage between patients operated with CLS (18.8% (95% CI: 8–17%)) and those operated with SPLS (15% (95% CI: 0–18%)) (p = 0.74). There were 37 re-operation/re-interventions in the CLS group (19.1%) and six in the SPLS group (16.7%). The difference between the two groups was not significant (p = 0.99). There were 22 re-admissions in the CLS-group and five in the SPLS-group. In the CLS-group, many of the re-admissions were due to nausea, dehydration, abdominal or perineal pain for which we found no cause or decrease in stoma output with spontaneous remission (n = 12). Other reasons were problems with bandaging of the stoma (n = 1), bleeding from the stoma that could be managed with a simple suture (n = 1), tachycardia (n = 1), macroscopic haematuria in a patient known to have cancer of the prostate (n = 1), defect in the perineal wound (n = 1), pelvic absces (n = 3), urinary tract infection (n = 1) and secretion from the rectal drain, which turned out to be old faeces in the rectum (n = 1). In the SPLS-group, the five re-admissions were due to problems with bandaging of the stoma (n = 1), pain in the perineum with unknown cause (n = 1), suspicion of deep vein thrombosis (DVT) (n = 1), apoplexia (n = 1) and one patient was re-admitted due to high fever. The white blood cell count was elevated, but we did not find a focus of the infection. The patient got better on broad-spectrum antibiotics.

There were six deaths within 30 days after surgery in the CLS-group. One patient, an 80-year-old man, developed mulitorgan failure following anastomotic leak and laparotomy. Another patient died of sepsis and multiorgan failure. This 78-year-old man underwent laparoscopic resection of the colon sigmoideum due to necrotic left colon. Two patients, an 80-yearold man and an 87-year-old man, underwent emergency laparotomy on suspicion of anastomotic leak. We found perforation of the small bowel, probably caused by thermal injury of the small bowel during the laparoscopic procedure. One patient, an 81-year-old man who was converted to open procedure due to severe intraabdominal obesity, developed an ileus and died due to progressive cardiovascular failure after re-operation. The sixth and last patient who died was an 88-year-old woman who developed an ileus due to a parastomal hernia. She was reoperated but died later due to multiorgan failure. Two patients in the SPLS-group, one 73-year-old and one 83-year-old woman, died within 30 days of surgery. The cause of their deaths is not known. Neither of them had any intra-or postoperative complications, and both had an uneventful postoperative course. They were discharged from the hospital on the 8th and 9th postoperative day and died at home on their 19th and 14th postoperative day, respectively. The median length of the hospital stay did not differ between the two groups (p = 0.38). There was a tendency towards fewer late complications in patients operated with SPLS compared to

218

K. Levic & O. Bulut

Table III. Procedural details and perioperative data. CLS

SPLS

0.1b

Procedure, n (%) LAR-l

78 (40.2)

9 (25)

LAR

39 (20.1)

11 (30.6)

APR

39 (20.1)

10 (27.8)

3 (1.5)

2 (5.6)

APR (intersphincteric)

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

HO

p-values

35 (18)

4 (11.1)

Median OR time, min (range)

248 (51–431)

295 (108–465)

0.01a

Median estimated blood loss, mL (range)

100 (0–3142)

35 (0–400)

0.006a

Conversions, n (%), [95% CI]

13 (6.7) [3–10]

5 (13.9) [2–26]

0.17b

Intraoperative complications, n (%), [95% CI]

14 (7.2) [4–11]

0 (0) [0]

0.14b

Morbidity, n (%), [95% CI]

80 (41.2) [34–48]

10 (27.8) [12–43]

Perineal wound dehiscence

5

0

Superficial wound infection

6

2

Deep wound infection

2

0

Parastomal hernia

1

0

Stoma necrosis

5

0

Left colonic necrosis

2

0

Thermal bowel injury

2

0

AL

22

3

AL requiring reoperation

12 (6.1%) [2.8–9.6]

2 (5.6%) [0–13]

Rectal stump leakage

3

1

Pelvic abscess

3

2

Ileus

3

0

Compartment syndrom in calf

1

1

11

1

9

1

Urinary tract infection Urinary retention Sepsis

1

0

Pneumonia

3

0

Arrythmia

2

0

Myocardial infarct

1

0

1

1

Apoplexia Late complications, n (%), [95% CI] Hernias

49 (25.3) [19–31]

4 (11.1) [0–22]

24

2

Incisional hernia

7

0

Parastomal hernia

15

2

2

0

Perineal hernia Stomal prolapse

2

1

Stenosis of anastomosis

7

0

Ileus

2

0

Pelvic abscess

2

0

Rectovaginal fistula

1

0

Perineal wound dehiscence

4

0

0.14b

0.08b

Short-term outcomes of conventional and single-port laparoscopic surgery for rectal cancer

219

Table III. (Continued). CLS

p-values

Superficial wound infection

3

0

Feacal incontinence

1

0

Coccydynia

1

1

Length of stay, days (range)

7 (3–80)

7 (3–51)

0.38a

22 (11.3) [7–16]

5 (13.9) [2–26]

0.59b

6 (3.1) [1–6]

2 (5.6) [0–13]

0.62b

Readmissions, n (%), [95% CI] 30-days mortality, n (%), [95% CI]

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

SPLS

LAR-l = low anterior resection with protective ileostomy; LAR = low anterior resection; APR = abdominoperineal resection; HO = Hartmann’s operation; OR time = total procedure time; AL = anastomotic leakage; Morbidity = number of patients with one or more complications. a Mann-Whitney test. b Fisher’s exact test.

those operated with CLS (11.1% vs. 25.3%), but the difference was not significant (p = 0.08).

Oncological outcome The oncological results are shown in Table IV. There was only one patient in each group with a positive resection margin. These two patients were referred to further treatment with chemotherapy. During the follow-up period there were no local recurrences among the patients operated with SPLS, whereas two patients in the CLS-group developed local recurrences: One patient, who also had prostate cancer with lymph node metastases, primarily operated with a Hartmann procedure due to a T2N0 tumour, developed peritoneal carcinosis 11 months after surgery. The patient was referred to chemotherapy. The other patient, also operated with a Hartmann procedure due to a T4N1 tumour with metastasis to the liver, developed a local recurrence 31 months postoperatively. The patient was referred to chemoradiation therapy.

Discussion Today, CLS is considered the method of choice in many abdominal surgical procedures. The role of laparoscopic colorectal surgery has increased, as it has been shown that the oncological outcome and morbidity remain equivalent to the open surgery approach, while the re-convalescence period has shortened (12–15). There are still some complications associated with CLS, such as bleeding, infection, incisional hernias and damage to the visceral organs. New minimally invasive techniques, such as NOTES and SPLS, have the potential to reduce these potential complications, including incision-related complications, along with the potential of improvement in quality of life

regarding cosmetic outcome and post-operative pain (16). Technological improvements including the use of a robotic platform and new devices are promising in facilitation of the SP approach. (17,18). Recently, a study of Weiss et al. found a low rate (2.53%) of wound complications after single-incision laparoscopic procedures, with no major differences between the types of procedure performed (19). The benefits of NOTES include no visible scars. However, the technique can be challenging with a long learning curve, and can also lead lead to potentially serious and fatal complications in case of incomplete visceratomy closure (20). SPLS, on the other hand, uses the same principles known from CLS, only reduced to a single port. SPLS is already successfully being performed in many abdominal procedures such as appendectomy and cholecystectomy (3,4). A recent systematic review and meta-analysis suggests that SP colorectal surgery is feasible and safe (21). There are only a few studies reporting SPLS in colorectal surgery and most of them consist of series of limited numbers of patients with SPLS being performed on both malignant and benign lesions (22–29). It is therefore difficult to draw any certain conclusions. The literature on SPLS in rectal surgery is still limited, and to our knowledge our study is the first addressing the role of SPLS for rectal cancer compared with CLS. All patients included in our study had rectal cancer, and all the SPLS were performed with a curative intent. The results show little difference between the laparoscopic and SP access. There was a significantly longer operative time in the SPLS-group, which can be explained by the limited experience with this new approach. Other comparative studies on SPLS versus CLS performed in colorectal procedures showed no difference in median operative time (23,30,31). In a study by Yun et al. comparing single-incision right colectomy with conventional laparoscopy, a shorter operation time was found in patients operated by

220

K. Levic & O. Bulut

Table IV. Oncological outcome.

Preoperative chemo- or radiation therapy, n (%), [95% CI]

CLS

SPLS

p-values

53 (27.3) [21–34]

8 (22.2) [8–36]

0.68b 0.12b

Staging *, n (%)

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

No residual tumour

7 (3.6)

1 (2.8)

Stage I

36 (18.6)

6 (16.6)

Stage II

70 (36.1)

15 (41.7)

Stage III

56 (28.9)

13 (36.1)

Stage IV

25 (12.9)

1 (2.8)

16 (1–48)

13 (3–33)

Median harvested lymph nodes, n (range)

0.72b

MRF, n: C

0.047a

133 (68.4)

26 (72.2)

NC

37 (19.1)

8 (22.2)

IC

22 (11.3)

2 (5.6)

9 (0–55)

10 (1–43)

0.19a

Median DRM, mm

25 (0–95)

30 (5–75)

0.72a

Median length of resected specimen,cm (range)

19 (10–43)

17 (10–35)

0.82a

Adjuvant treatment, n (%), [95% CI]

92 (47.7) [41–55]

14 (38.9) [22–56]

0.37b

Median CRM, mm (range)

Locoregional recurrence, n (%), [95% CI]

3 (1.5) [0–3]

Distant metastasis, n (%), [95% CI]

29 (15) [10–20]

Median follow-up, months (range)

13 (1–62)

0 (0) [0]

0.99b

2 (5.6) [0–13]

0.18b

10 (1–33)

0.45a

*American Joint Committee on Cancer staging system. MRF = mesorectal fascia; C = complete; NC = nearly complete; IC = incomplete; CRM = circumferential resection margin; DRM = distal resection margin. a Mann-Whitney test. b Fisher’s exact test.

single-incision (32). However, when only procedure time was analyzed, the difference was not significant. The median operative time is expected to decrease as more procedures are performed and experience gained, as it did with CLS in the colorectal field. The median operative blood loss was however significantly lower in the SPLS-group. One concern with SPLS surgery is the technical feasibility, especially in rectal surgery, where the operative space is limited by the pelvic bone wall and technically more demanding. This could potentially create a higher complication rate. In our study, there were no intraoperative complications in the SPLS group. Another measurement of the technical difficulty is the conversion rate. There was no difference in conversion between the two groups. In the SPLS-group, five patients (13.9%) required an additional port or conversion to CLS, and there were no conversions to laparatomy. These results do not differ from other studies about SPLS in colorectal procedures. A study by Sirikurnpiboon et al. on single-access rectal surgery showed a conversion rate of 0%. They reported post-operative complications in

six cases (60%), but none of them were serious complications (6). There were only ten patients included in the study, which makes the results difficult to interpret. A systematic review and metaanalysis on single incision laparoscopy for colorectal resection by Maggiori et al. reported a conversion rate of 25% to multiport laparoscopy and 3% to laparotomy for single-incision rectal procedures (21). Osbourne et al. reported that patients having SP colorectal surgery were more likely to develop urinary retention than CLS-patients, but there was no difference between the two groups regarding serious complications (25). In our study, the post-operative complication rate was lower in the SPLS-group, but the difference was not significant. Not all of the complications were serious, and there was no difference in the occurrence of anastomotic leakage. Much depends on the author’s definition of anastomotic leakage when it comes to calculating leakage rates. We have used wide spanning criteria for our definition of anastomotic leaks. Our rates of leakages that required reoperation is acceptable in comparison with other series (33–35). Neither conversion nor

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

Short-term outcomes of conventional and single-port laparoscopic surgery for rectal cancer neoadjuvant therapy resulted in a higher risk of development of anastomotic leakage in this series. We found a tendency toward fewer late complications in the SPLS-group, with the main difference being in the number of hernias. However, the follow-up time needs to be longer in order to evaluate the longterm outcomes on both hernia formation and other late complications. Cost analysis of a new procedure such as SP surgery has been another issue of debate in the surgical community. We used conventional laparoscopic instruments in both groups. The differences between these two groups were using a SP kit set that includes a single-port with three trocars and EndoGIA with two cartriges. The estimated cost of these disposible instruments was approximately 967,045 $ in our institution. We used the five-trocar technique in CLS patients which costs 628,475 $ and the laparoscopic rectal transection in the great majority of our patients was done with a curved cutter stapler which costs 433,495 $, with a total amount of approximately 1061, 98 $. Therefore, we can clearly state that the material costs of these two groups of approaches were comparable. The oncological outcome is an important factor when assessing any novel approach in cancer surgery, as any new technique will quickly be rejected if it compromises oncological safety. A concern with single-port access surgery is that the maneuverability of the instruments with instrument crowding can hamper surgical dissection and margin clearance. In our study, the early oncological parameters were comparable between the two groups. This shows that the principles of total mesorectal excision are applicable when using only a single port. The number of harvested lymph nodes is a parameter of quality and detection of lymph node metastasis is essential for prognosis and treatment (36,37). The presence of lymph node metastasis is one of the most important prognostic factors for long-term outcome in colorectal cancer, as examining more lymph nodes will improve the accuracy of staging, resulting in the right treatment for more patients (34). In this study, there were more harvested lymph nodes in the group operated with CLS (16 vs. 13, p = 0.047). One possible explanation is that there was a tendency towards smaller and early stage cancer in SPLS-patients. However, in both groups, the median number of harvested lymph nodes was higher than 12, which is the recommendation of the least number of harvested lymph nodes by both national and international guidelines (9,37). Other studies comparing SPLS with CLS for colorectal diseases showed no difference in the number of extracted lymph nodes (31,32). Two studies found a higher number of extracted lymph nodes in patients operated with

221

SPLS, but this was explained by the change of practice of the local histopathologists (23,25). A randomized controlled trial on single-incision versus conventional laparoscopic colectomy for neoplasm showed no difference in the number of lymph nodes extracted or the resection margins (38). Overall, the results in our study, and others on SPLS on colorectal procedures, show that SPLS does not compromise the oncological factors. However, the use of SP in rectal surgery is still in its infancy and at present there is no evidence that shows a worse patient outcome than for CLS. There are some limitations to this study. One is the follow-up time, which limits us from drawing conclusions on long-term effects. Another limitation is the difference in the number of patients in the two groups. Also, this study lacks measurement of the incision length in the SPLS-group, as well as comparison of post-operative pain. Patients in the SPLS group had less blood loss. However, the multiport group had a statistically higher BMI and SPLS was performed only in selected cases. This could explain the lower blood loss within the SPLS group, as this is biased by the selection. Although this is the largest study on SPLS for rectal surgery, the limited number of patients and selection bias in this study can result in an overestimation of the results.

Conclusion SPLS for rectal cancer is safe and feasible, with comparable surgical and oncological outcomes as compared to CLS in highly selected patients. SPLS in rectal surgery is still new, and should be performed in selected patients by experienced laparoscopic colorectal surgeons. Large, well-designed randomized controlled trials with appropriate outcomes are warranted to determine the true benefits of this novel technique in routine clinical practice. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

References 1. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006;93:921–8. 2. Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, et al. MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005;365:1718–26.

Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Otago on 12/28/14 For personal use only.

222

K. Levic & O. Bulut

3. Ahmed K, Wang TT, Patel VM, Nagpal K, Clark J, Ali M, et al. The role of single-incision laparoscopic surgery in abdominal and pelvic surgery: a systematic review. Surg Endosc. 2011;25:378–96. 4. Romanelli JR, Earle DB. Single-port laparoscopic surgery: an overview. Surg Endosc. 2009;23:1419–27. 5. Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, et al. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101:283–6. 6. Sirikurnpiboon S, Jivapaisarnpong P. Single-access laparoscopic rectal surgery is technically feasible. Minim Invasive Surg. 2013;2013:687134. 7. Bulut O, Nielsen CB. Single-incision laparoscopic low anterior resection for rectal cancer. Int J Colorectal Dis. 2010;25:1261–3. 8. Bulut O, Nielsen CB, Jespersen N. Single-port access laparoscopic surgery for rectal cancer: initial experience with 10 cases. Dis Colon Rectum. 2011;54:803–9. 9. Danish Colorectal Cancer Group (DCCG) Guidelines 4th edition 2009. http://www.dccg.dk/10_English/0010_English.html. 10. Aslak KK, Bulut O. The implementation of a standardized approach to laparoscopic rectal surgery. JSLS. 2012;16:264–70. 11. Bulut O, Aslak KK, Rosenstock S. Technique and short-term outcomes of single-port surgery for rectal cancer: a feasibility study of 25 patients. Scand J Surg. 2013;Epub ahead of print. 12. Ahmad NZ, Racheva G, Elmusharaf H. A systematic review and meta-analysis of randomized and non-randomized studies comparing laparoscopic andopen abdominoperineal resection for rectal cancer. Colorectal Dis. 2013;15:269–77. 13. The Colon Cancer Laparoscopic or Open Resection Study Group. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomisedclinical trial. Lancet Oncol. 2009;10:44–52. 14. Lourenco T, Murray A, Grant A, McKinley A, Krukowski Z, Vale L. Laparoscopic surgery for colorectal cancer: safe and effective? - A systematic review. Surg Endosc. 2008;22:1146–60. 15. Lacy AM, Delgado S, Castells A, Prins HA, Arroyo V, Ibarzabal A, et al. The long-term results of a randomized clinical trial of l aparoscopy-assisted versus open surgery for colon cancer. Ann Surg. 2008;248:1–7. 16. Lirici MM. Single site laparoscopic surgery: an intermediate step toward no (visible) scar surgery or the next gold standard in minimally invasive surgery? Minim Invasive Ther Allied Technol. 2012;21:1–7. 17. Tang B, Hou S, Cuschieri A. Ergonomics of and technologies for single-port laparoscopic surgery. Minim Invasive Ther Allied Technol. 2012;21:46–54. 18. Kanehira E, Siozawa K, Kamei A, Tanida T. Development of a novel multichannel port (x-Gate()) for reduced port surgery and its initial clinical results. Minim Invasive Ther Allied Technol. 2012;21:26–30. 19. Weiss HG, Brunner W, Biebl MO, Schirnhofer J, Pimpl K, Mittermair C, et al. Wound complications in 1145 consecutive transumbilical single-incision laparoscopic procedures. Ann Surg. 2014;259:89–95. 20. Flora ED, Wilson TG, Martin IJ O’Rourke NA, Maddern GJ. A review of natural orifice translumenal endoscopic surgery (NOTES) for intra-abdominal surgery: experimental models, techniques, and applicability to the clinical setting. Ann Surg. 2008;247:583–602. 21. Maggiori L, Gaujoux S, Tribillon E, Bretagnol F, Panis Y. Single-incision laparoscopy for colorectal resection: a systematic review and meta-analysis of more than a thousand procedures. Colorectal Dis. 2012;14:e643–54. 22. Gaujoux S, Maggiori L, Bretagnol F, Ferron M, Panis Y. Safety, feasibility, and short-term outcomes of single port

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

35.

36.

37.

38.

access colorectal surgery: a single institutional case-matched study. J Gastrointest Surg. 2012;16:629–34. Kanakala V, Borowski DW, Agarwal AK Tabaqchali MA, Garg DK, Gill TS. Comparative study of safety and outcomes of single-port access versus conventional laparoscopic colorectal surgery. Tech Coloproctol. 2012;16:423–8. Palanivelu C, Vij A, Rajapandian S, Palanivelu P, Parthasarathi R, Vaithiswaran V, et al. Single incision laparoscopic colorectal resection: our experience. J Minim Access Surg. 2012;8:134–9. Osborne AJ, Lim J, Gash KJ, Chaudhary B, Dixon AR. Comparison of single-incision laparoscopic high anterior resection with standard laparoscopic high anterior resection. Colorectal Dis. 2013;15:329–33. van den Boezem PB, Sietses C. Single-incision laparoscopic colorectal surgery, experience with 50 consecutive cases. J Gastrointest Surg. 2011;15:1989–94. Chambers WM, Bicsak M, Lamparelli M, Dixon AR. Single-incision laparoscopic surgery (SILS) in complex colorectal surgery: a technique offering potential and not just cosmesis. Colorectal Dis. 2011;13:393–8. Vestweber B, Galetin T, Lammerting K, Paul C, Giehl J, Straub E, et al. Single-incision laparoscopic surgery: outcomes from 224 colonic resections performed at a single center using SILS. Surg Endosc. 2013;27:434–42. Al Sabah S, Liberman AS, Wongyingsinn M, Charlebois P, Stein B, Kaneva PA, et al. Single-port laparoscopic colorectal surgery: early clinical experience. J Laparoendosc Adv Surg Tech. A. 2012;22:853–7. Lu CC, Lin SE, Chung KC, Rau KM. Comparison of clinical outcome of single-incision laparoscopic surgery using a simplified access system with conventional laparoscopic surgery for malignant colorectal disease. Colorectal Dis. 2012;14:e171–6. Mynster T, Hammer J, Wille-Jørgensen P. Preliminary results after single-port laparoscopic colonic surgery. Dan Med J. 2012;59:A4551. Yun JA, Yun SH, Park YA, Cho YB, Kim HC, Lee WY, et al. Single- incision laparoscopic right colectomy compared with conventional laparoscopy for malignancy: assessment of perioperative and short-term oncologic outcomes. Surg Endosc. 2013;27:2122–30. Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, et al. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicenter, randomized controlled trial. Lancet. 2005;365:1718–26. Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009;96:982–9. Sartori CA, Dal Pozzo A, Franzato B, Balduino M, Sartori A, Baiocchi GL. Laparoscopic total mesorectal excision for rectal cancer: experience of a single center with a series of 174 patients. Surg Endosc. 2011;25:508–14. Pheby DF, Levine DF, Pitcher RW, Shepherd NA. Lymph node harvests directly influence the staging of colorectal cancer: evidence from a regional audit. J Clin Pathol. 2004;57:43–7. Compton C, Fenoglio-Preiser CM, Pettigrew N, Fielding LP. American Joint Committee on Cancer prognostic factors consensus conference: colorectal working group. Cancer. 2000;88:1739–57. Poon JT, Cheung CW, Fan JK, Lo OS, Law WL. Single-incision versus conventional laparoscopic colectomy for colonic neoplasm: a randomized, controlled trial. Surg Endosc. 2012;26:2729–34.

The short-term outcomes of conventional and single-port laparoscopic surgery for rectal cancer: a comparative non-randomized study.

Single-port laparoscopic surgery (SPLS) has evolved as an alternative method to conventional laparoscopic surgery (CLS). The aim of this study is to e...
165KB Sizes 2 Downloads 0 Views