Original Article Received: July 21, 2014 Accepted after revision: November 18, 2014 Published online: January 27, 2015
Gynecol Obstet Invest DOI: 10.1159/000370000
Single Incision Trans-Umbilical Total Hysterectomy: Robotic or Laparoscopic? Ali Akdemir a Nuri Yildirim c Burak Zeybek a Semra Karaman b Fatih Sendag a
Departments of a Obstetrics and Gynecology and b Anesthesiology and Reanimation, Ege University Faculty of Medicine, and c Dokuz Eylul University Faculty of Medicine, Department of Obstetrics and Gynecology, İzmir, Turkey
Abstract Objective: The aim of this study was to compare the early surgical outcomes in patients who underwent total hysterectomy with laparoendoscopic single-site surgery (LESS-TH) versus robotic single-site total hysterectomy (RSSTH). Methods: Twenty-four patients who underwent RSSTH and thirty-four patients who underwent LESS-TH were retrospectively evaluated. Patient characteristics, operation time, intraoperative data (conversions, complications, estimated blood loss, etc.) and postoperative pain scores were compared. Results: The total operation time was significantly longer in the robotic surgery group, with a time of 98.5 vs. 86 min (p = 0.013), while vaginal closure time was significantly higher in the laparoscopic surgery group (p = 0.011). Intraoperative outcomes and postoperative pain scores were similar in the two groups. Conclusion: RSS-TH helps surgeons to overcome the technical disadvantages of LESS-TH, particularly vaginal cuff closure, ergonomics and instrument crowding and clashing. Early surgical outcomes are comparable in the two groups, and both techniques are safe and feasible. © 2015 S. Karger AG, Basel
© 2015 S. Karger AG, Basel 0378–7346/15/0000–0000$39.50/0 E-Mail [email protected] www.karger.com/goi
Introduction
Innovations in endoscopy have brought new advancements in surgical fields in the last three decades. Gynecologic surgery takes the lead in this area. Not only benign cases, such as cystectomies, hysterectomies, myomectomies, but also malignant conditions, such as endometrial and cervical cancer operations, can be performed by endoscopy [1]. Laparoscopy is a minimally invasive technique, but studies on how these surgeries can be achieved less invasively are still ongoing. The decrement in the number of incisions and use of a single-incision technique are the focus of laparoscopic surgery. Many terms are used for single-incision techniques, such as single-port laparoscopy (SPL), single-port incision-less conventional equipment-utilizing surgery (SPICES), single-incision laparoscopic surgery (SILS), single-access endoscopic surgery (SAES), natural-orifice trans-umbilical surgery (NOTUS), one-port umbilical surgery (OPUS), and laparoendoscopic single-site surgery (LESS). It has been reported that LESS is feasible and safe for many gynecological procedures with better cosmetic results and less potential morbidity than multiple incisions [2–5]. However, LESS also has some well-known technical disadvantages that prevent this technique from being a standard technique, namely, crowding and clashing of instruments, loss of Fatih Şendağ, Professor Ege University Faculty of Medicine, Department of Obstetrics and Gynecology Ege Üniversitesi Tıp Fakültesi, Kadın Hastalıkları ve Doğum Anabilim Dalı TR–35100 Bornova/İzmir (Turkey) E-Mail fatih.sendag @ ege.edu.tr
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Key Words Hysterectomy · Laparoscopy · Robotic surgery · Single-port laparoscopy
Materials and Methods Patients who underwent robotic single-site total hysterectomy (RSS-TH) and laparoscopic single-site total hysterectomy (LESSTH) for benign gynecological indications in Ege University, Faculty of Medicine, Department of Obstetrics and Gynecology between January 2012 and December 2013 were included in this study. All operations using either the RSS-TH or LESS-TH technique during the study period were included for analysis. Data were collected retrospectively, and approval was obtained from our Institutional Review Board. Exclusion criteria for both surgical techniques were as follows: confirmed or suspicious gynecological malignancies, uterine size greater than 16 weeks gestational size on pelvic examination, history of endometriosis, and co-morbidities that are contraindications for laparoscopic surgery or prolonged Trendelenburg position, such as cardiopulmonary diseases. All surgical procedures were performed by the same surgeon (FS) experienced in advanced laparoscopic and robotic surgery. The surgical procedures were explained to all patients, and alternative techniques were discussed. All patients gave their informed consent. Surgical Technique for RSS-TH The da Vinci Single-Site robotic surgery platform (Intuitive, Sunnyvale, Calif., USA) and the da Vinci Single-Site Port were used for RSS-TH. This port included two curved cannulas for robotically controlled instruments and two straight cannulas for an 8.5 mm high definition endoscope and a 5 mm bed-side assistant surgeon port. The curved cannulas transmit interchangeable semirigid instruments that cross each other within the trocar so that the instrument that enters on the right becomes the left-sided operative instrument and vice versa. The da Vinci Si Surgical System automatically reassigns the Single-Site Platform instruments after docking so that the left hand of the surgeon will control the right arm of the robot and vice versa. Robotic instruments were 5 mm, non-wristed and semi-rigid, allowing them to be inserted through the curved cannulas. Although this new set-up was initially
2
Gynecol Obstet Invest DOI: 10.1159/000370000
launched without the inclusion of a bipolar grasping instrument, the bipolar grasper has been recently developed and is currently available. The Single-Site Port was inserted into the abdominal cavity after abdominal access was achieved via an open technique with a vertical intra-umbilical incision up to 2.5 cm in length. The optical port and laparoscope were then inserted and abdominopelvic visualization was achieved. Under direct visualization, two curved cannulas were then inserted. After the robot was docked centrally to the patient, a monopolar hook instrument and grasping instrument with or without the bipolar feature were inserted through robotic arm 2 and arm 1, respectively. Afterwards, the surgeon (FS) sat at the console; the instrument orientation was confirmed so that the left hand of the surgeon at the console controlled the left instrument (robotic arm 1) in the operative field despite the curved cannulas forming an opposite confirmation. Bilateral infundibulopelvic (IP) ligaments and round ligaments were sealed and transected with EnSeal (SurgRx Inc., Calif., USA) through the assistant port for the initial 12 operations. In contrast, IP and round ligaments were sealed and transected with bipolar and monopolar instrument, respectively, for the latter 12 cases. After developing a bladder flap, the uterine vessels were skeletonized with monopolar instruments. The uterine vessels were then sealed and transected in the same manner as IP ligaments. Afterwards, a circumferential colpotomy was performed using the monopolar instrument, the vaginal cuff was closed intracorporeally with intra-corporeal single stitches using da Vinci Single-Site Platform instruments in all cases. The RSS-TH surgical technique was described in detail in our previous reports [9–11]. Surgical Technique for LESS-TH The TriPort (Olympus America Inc., Pa., USA), multichannel single port, which allows three 5 mm laparoscopic instruments was used for the LESS-TH technique. The Endoeye 5 mm flexible laparoscope and Thunderbeat (Olympus America Inc., Pa., USA) were used for endoscopic visualization and sealing-transecting, respectively. Other instruments for grasping and suturing were the same rigid, straight instruments used for conventional multiport laparoscopy. After an intraumbilical vertical incision up to 2.5 mm was created, abdominal access was achieved and TriPort was inserted into the abdominal cavity. Bilateral IP and round ligaments were sealed and transected with Thunderbeat. Afterwards, a bladder flap was developed and the uterine vessels were skeletonized with the same instrument. A circumferential colpotomy was then performed using Thunderbeat again. At the final step, the vaginal cuff was closed laparoscopically with single stiches and an extracorporeal knot-tying technique. The LESS-TH surgical technique has been described in detail in a previous report [3]. Patient characteristics, including age, body mass index (BMI), length of hospital stay and history of previous abdominal surgery, were recorded. Perioperative data including estimated blood loss (EBL) (calculated by determining the difference between the volume of the fluid used for irrigation and suction at the end of the procedure), intraoperative complications, conversion to laparoscopy or laparotomy, post-hysterectomy uterine weight and operation time were recorded. Operation time was divided into subgroups as follows: set-up time (time between the start of the anesthetics and the first incision), port placement time (time between the first incision and the end of successful port placement),
Akdemir/Yildirim/Zeybek/Karaman/ Sendag
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depth perception, ergonomic difficulties, loss of instrument triangulation, the need for advanced laparoscopic skills and a long learning curve [2, 3]. Recently, the robotic surgical system has been introduced to modern surgical practice. This system improved surgeon dexterity, visualization, ergonomics and surgical precision with the help of wristed instrumentation [6]. However, the robotic system required an increased number and size of ports. In accordance with a minimally invasive vision, LESS and robotic systems have been integrated, and single-site robotic surgery in gynecological practice has been reported [7–9]. The da Vinci Single-Site robotic surgery platform (Intuitive, Sunnyvale, CA, USA) was designed for this technique. The purpose of this study was to compare early surgical outcomes in patients who underwent total hysterectomy with LESS and the robotic single-site technique.
Table 1. Patient characteristics
Age, years Body mass index, kg/m2 Previous laparotomy, n (%)
RSS-TH (n = 24)
LESS-TH (n = 34)
p value
49.5 (40–61) 28.5 (21.7–34.2) 18 (75)
51.5 (44–67) 27.45 (22.5–34.5) 24 (70.6)
0.38 0.93 0.71
RSS-TH = Robotic single site total hysterectomy; LESS-TH = laparoendoscopic single site total hysterectomy.
Results
Twenty four patients who underwent RSS-TH and thirty four patients who underwent LESS-TH were included in this study. The median age and BMI in the RSSTH group were 49.5 and 28.5 kg/m2, respectively. In the LESS-TH group, the median age was 51.5 and the median BMI was 27.45 kg/m2. A total of 18 patients in the RSS-TH group and 24 patients in the LESS-TH group had a history of at least one previous abdominal surgery. There was no significant difference in age, BMI and history of previous abdominal surgery between the two groups, with p values of 0.38, 0.93 and 0.71, respectively (table 1). Single Port Total Hysterectomy: Robotic versus Laparoscopic
The estimated blood loss in the two different techniques is similar, with 22.5 ml in the RSS-TH group and 25 ml in the LESS-TH group (p = 0.38). None of the patients needed a blood transfusion. The operation time was significantly longer in the robotic surgery group, at 98.5 vs. 86 min (p = 0.013). Vaginal closure time was significantly higher in the laparoscopic surgery group (p = 0.011), while hysterectomy time was significantly longer in the robotic surgery group (p = 0.01) (table 2). There was no considerable difference between the two groups in setup time and port placement time (p = 0.072 and p = 0.35, respectively). The mean uterine weight was significantly higher in the robotic surgery group (p = 0.026). In the RSS-TH group, EnSeal (SurgRx Inc., Calif., USA) was used in 12 patients as a sealing device, while bipolar Single-Site Robotic instrument were used in 12 patients. Thunderbeat (Olympus America Inc., Pa., USA) was used for sealing in all patients in the LESS-TH group. There were no differences between the RSS-TH and LESS-TH group in postoperative pain scores (table 3). Similar rating scores were obtained in the LESS-TH group and the RSS-TH in overall satisfaction with surgery (9.0 ± 0.8 vs. 9.2 ± 0.4) and cosmetic appearance (8.9 ± 0.5 vs. 8.4 ± 0.7). Conversion to conventional laparoscopy or laparotomy did not occur in either group. There were no surgical complications in either group. The length of hospital stay after surgery was similar in both groups (p = 0.92). The mean follow-up after surgery was 9 months in the RSS-TH group and 12 months in the LESS-TH group. There were no surgical complications in either group during these periods.
Discussion
Laparoscopic surgery began with tubal ligations in the gynecological field in the 1970s [13]. Since then, developments in technology and techniques have made minimally invasive surgery the main goal of all surgeons. In gyneGynecol Obstet Invest DOI: 10.1159/000370000
3
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operation time (time between the skin incision and skin closure), hysterectomy time (time between the end of port placement and the beginning of vaginal closure), and vaginal cuff closure time (time between the insertion of the robotic single-site or laparoscopic needle holder to the abdomen and removal at the end of the closure). Postoperative pain was evaluated in all patients. One day before the operation, patients received instructions about the use of a patient-controlled analgesic device (APM; Abbott Laboratories, North Chicago, Ill., USA) and a visual analog scale (VAS) for pain. This scale consisted of an unmarked 10 cm line on which 0 cm represented no pain and 10 cm represented the worst pain imaginable. In the postoperative care unit, all patients had access to intravenous analgesia with morphine via a patient-controlled analgesic device. The settings of the device were as follows: loading dose of 0.05 mg/kg, bolus dose of 0.02 mg/kg, no continuous background infusion, lockout time of 15 min, and no 4 h maximum. Patients were given additional analgesic (diclofenac sodium, 75 mg intramuscularly (Voltaren R; Novartis Pharmaceuticals Corp., East Hanover, N.J., USA) when analgesia was inadequate (VAS score >3). Pain was assessed using VAS at 1, 2, 4, 6, 12 and 24 h after surgery. Patients were also requested to rate their overall satisfaction with the surgical procedure and cosmetic appearance on separate questionnaires [12]. The normality assumption was not met when the data were assessed with the Kolmogorov-Smirnov test, indicating that the data were nonparametric. Thus, the Mann-Whitney U test and Chisquare test were used for comparisons. The data were analyzed using the SPSS 20.0 software package (Chicago, Ill., USA). Statistical significance was defined as p < 0.05.
Table 2. Surgical outcomes
Estimated blood loss (EBL), ml Operation time, min Setup time Port placement time Docking time Console time Hysterectomy time Vaginal closure time Uterine weight, mg Conversion Complications Length of hospitalization after surgery, days
RSS-TH (n = 24)
LESS-TH (n = 34)
p value
22.5 (40–61) 98.5 (71–183) 22 (16–28) 8 (5–11) 5.5 (3–10) 74.5 (60–160) 53.5 (44–120) 21 (16–41) 192.5 (65–520) – – 1.6 (1–3)
25 (44–67) 86 (59–140) 24 (19–32) 7 (4–12) NA NA 43 (27–85) 26.5 (18–49) 117.5 (50–535) – – 1.8 (1–4)
0.38 0.013 0.072 0.35 NA NA 0.01 0.011 0.026 NA NA 0.92
RSS-TH = Robotic single site total hysterectomy; LESS-TH = laparoendoscopic single site total hysterectomy; NA = not applicable.
RSS-TH (n = 24) LESS-TH (n = 34) p value VASa 1st hour 6 (3–8) 2nd hour 6 (3–7) 4th hour 4 (2–6) 6th hour 3 (1–4) 12th hour 2 (0–3) 24th hour 1 (0–3) Total morphine consumption at 24 h, mgb 16.2 (9.7–26.1)
5.5 (3–7) 6 (2–7) 4 (1–6) 2 (1–4) 2 (0–4) 1 (0–2) 13.6 (10.2–26.8)
0.6 0.5 0.6 0.7 0.5 0.6 0.6
a
Values are given as median (range). b Values are given as median (range). RSS-TH = Robotic single site total hysterectomy; LESS-TH = laparoendoscopic single site total hysterectomy; VAS = visual analog scale.
cology today, almost all procedures can be performed endoscopically. Recently, a new method, single-site surgery was introduced in the field of minimally invasive surgery and initial reports have discussed the feasibility of this technique [3, 7–9]. Since the introduction of robotic surgery, laparoendoscopic single-site surgery has been integrated with robotics, and two means of single-site endoscopic surgery have emerged. In our study, we evaluated and compared the early surgical outcomes of these two techniques, robotic and laparoscopic single-site surgeries, in total hysterectomy operations. 4
Gynecol Obstet Invest DOI: 10.1159/000370000
Hysterectomy is one of the most common gynecologic surgeries and approximately 600,000 hysterectomies are performed annually in the United States; the rate of laparoscopic hysterectomies is increasing day by day worldwide [14]. With the minimally invasive approach, the single incision laparoscopic technique has both advantages over laparotomy, such as faster return to normal activities, shorter duration of hospital stay, and reduced pain, as well as advantages over multi-incision laparoscopic surgery, such as improved cosmetics and reduced risks related to trocar insertion, for example, vessel injury, hematoma and infection [15–17]. Because of these advantages, single-site hysterectomy seems feasible but has considerable limitations, especially technical limitations, as previously mentioned. To the best of our knowledge, the present study is the first study that compares robotic single-site ‘total’ hysterectomy with conventional laparoscopic single-site ‘total’ hysterectomy in benign cases. In this study, both groups were similar in demographic features, including age, BMI and history of previous abdominal surgery. In both groups, the operations were performed with non-wristed (curved and semi-rigid instruments for RSS-TH, and rigid and straight instruments for LESS-TH) instruments and the cuff suturing was performed laparoscopically. Setup time and port placement time were similar in both groups. Hysterectomy time was longer in the RSS-TH group, which may be due to the heavier or bigger uteruses in the RSS-TH group; the median uterine weight in the RSS-TH group was significantly higher than the LESS-TH group. Conversely, vaginal Akdemir/Yildirim/Zeybek/Karaman/ Sendag
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Table 3. Comparison of postoperative scores in different types of hysterectomy
closure time was longer in the LESS-TH group. One of the most important advantages of robotic surgery is the comfort of the surgeon during the operation. Although the same experienced surgeon used the same type of sutures and non-wristed instruments for suturing in both groups, vaginal closure took more time in the LESS-TH group. The main reason might be the fatigue of the surgeon and the crowding and clashing of instruments that occurs in the LESS-TH technique. It may also be caused by the loss of instrument triangulation, which is important for laparoscopic suturing and is one of the main challenges to suturing in LESS surgery. The total operation time was longer in the RSS-TH group than the LESS-TH group, at 98.5 min versus 88 min, respectively. Additional time for docking and longer hysterectomy time are the main factors that contributed to the longer total operation time in the robotic surgery group. The estimated blood loss, postoperative pain scores, and length of hospital stay after surgery were similar in both groups. Conversion to conventional multiport laparoscopy or laparotomy did not occur in either group. All patients had excellent postoperative recovery without early and/or late complications. Our results were comparable with other studies. Jung et al reported that median operative time was 100 min for the LESS-TH technique in thirty patients [16]. Puntambekar et al. reported that the mean operative time was 88 min for the same technique [18]. In RSS-TH, the results were similar. Nam et al reported seven cases in which the median operative time was 109 min (105–311 min) [19]. In the latter study, the authors used EndoWrist Technology in their operations. The most similar study to ours was reported by Fagotti et al. [20]. The authors compared robotic single-site hysterectomy and laparoendoscopic single-site hysterectomy in 19 and 38 early endometrial cancer patients, respectively. The median operative time was 90 min
in the robotic group and 107 min in the laparoscopic group with no significant differences between the two groups (p = 0.354). The authors performed cuff closure vaginally and did not perform lymphadenectomy on any of the patients. They claimed that the two procedures were comparable. The retrospective nature of the present study serves as a limitation. As a result of this study design, the uterine weights were not equal between the two groups. Thus, the larger uterine size could have caused the prolonged operation time observed in the RSS-TH group compared to the LESS-TH group. However, it is unique observation in the present study that the vaginal cuff closure was faster and more comfortable in RSS-TH than LESS-TH. Although single-site surgery seems feasible, it has prominent technical difficulties, such as internal and external clashing between the instruments and the surgeons’ hands, respectively. The da Vinci Single-Site robotic surgery platform (Intuitive, Sunnyvale, Calif., USA) was introduced to overcome these disadvantages of conventional single-port laparoscopy. The robotic surgery platform improved surgeon dexterity, surgical precision, visualization and, most importantly, ergonomics and vaginal cuff closure. However, in addition to these advantages, robotic single-site surgery is not significantly superior to conventional single site laparoscopy in terms of early surgical outcomes. In our experience, both techniques are feasible and safe, as previously reported [3, 20–23]; however, singlesite surgery still requires innovations such as wristed/articulated instruments to have better surgical outcomes.
Disclosure Statement The authors declare that there are no conflicts of interest.
References
Single Port Total Hysterectomy: Robotic versus Laparoscopic
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19 Nam EJ, Kim SW, Lee M, Yim GW, Paek JH, Lee SH, Kim S, Kim JH, Kim JW, Kim YT: Robotic single-port transumbilical total hysterectomy: a pilot study. J Gynecol Oncol 2011;22:120–126. 20 Fagotti A, Corrado G, Fanfani F, Mancini M, Paglia A, Vizzielli G, Sindico S, Scambia G, Vizza E: Robotic single-site hysterectomy (RSS-H) vs. laparoendoscopic single-site hysterectomy (LESS-H) in early endometrial cancer: a double-institution case-control study. Gynecol Oncol 2013;130:219–223. 21 Escobar PF, Kebria M, Falcone T: Evaluation of a novel single-port robotic platform in the cadaver model for the performance of various procedures in gynecologic oncology. Gynecol Oncol 2011;120:380–384. 22 Escobar PF, Haber GP, Kaouk J, Kroh M, Chalikonda S, Falcone T: Single-port surgery: laboratory experience with the daVinci single-site platform. JSLS 2011;15:136–141. 23 Escobar PF, Knight J, Rao S, Weinberg L: da Vinci® single-site platform: anthropometrical, docking and suturing considerations for hysterectomy in the cadaver model. Int J Med Robot 2012;8:191–195.
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10 Sendag F, Akdemir A, Zeybek B, Ozdemir A, Gunusen I, Oztekin MK: Single-site robotic total hysterectomy: standardization of technique and surgical outcomes. J Minim Invasive Gynecol 2014;21:689–694. 11 Akdemir A, Zeybek B, Ozgürel B, Oztekin MK, Sendag F: Learning curve analysis of intracorporeal cuff suturing during robotic single-site total hysterectomy. J Minim Invasive Gynecol 2014, Epub ahead of print. 12 Akdemir A, Ergenoğlu AM, Akman L, Yeniel AÖ, Sendag F, Öztekin MK: A novel technique for laparoscopic removal of the fallopian tube after ectopic pregnancy via transabdominal or transumbilical port using homemade bag: a randomized trial. J Res Med Sci 2013; 18: 777–781. 13 Hulka JF: Current status of elective sterilization in the United States. Fertil Steril 1977;28:515–520. 14 Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG: Hysterectomy rates in the United States, 2003. Obstet Gynecol 2007; 110: 1091– 1095.
Gynecol Obstet Invest DOI: 10.1159/000370000
Single Incision Trans-Umbilical Total Hysterectomy: Robotic or Laparoscopic? Ali Akdemir a Nuri Yildirim c Burak Zeybek a Semra Karaman b Fatih Sendag a
Departments of a Obstetrics and Gynecology and b Anesthesiology and Reanimation, Ege University Faculty of Medicine, and c Dokuz Eylul University Faculty of Medicine, Department of Obstetrics and Gynecology, İzmir, Turkey
Abstract Objective: The aim of this study was to compare the early surgical outcomes in patients who underwent total hysterectomy with laparoendoscopic single-site surgery (LESS-TH) versus robotic single-site total hysterectomy (RSSTH). Methods: Twenty-four patients who underwent RSSTH and thirty-four patients who underwent LESS-TH were retrospectively evaluated. Patient characteristics, operation time, intraoperative data (conversions, complications, estimated blood loss, etc.) and postoperative pain scores were compared. Results: The total operation time was significantly longer in the robotic surgery group, with a time of 98.5 vs. 86 min (p = 0.013), while vaginal closure time was significantly higher in the laparoscopic surgery group (p = 0.011). Intraoperative outcomes and postoperative pain scores were similar in the two groups. Conclusion: RSS-TH helps surgeons to overcome the technical disadvantages of LESS-TH, particularly vaginal cuff closure, ergonomics and instrument crowding and clashing. Early surgical outcomes are comparable in the two groups, and both techniques are safe and feasible. © 2015 S. Karger AG, Basel
© 2015 S. Karger AG, Basel 0378–7346/15/0000–0000$39.50/0 E-Mail [email protected] www.karger.com/goi
Introduction
Innovations in endoscopy have brought new advancements in surgical fields in the last three decades. Gynecologic surgery takes the lead in this area. Not only benign cases, such as cystectomies, hysterectomies, myomectomies, but also malignant conditions, such as endometrial and cervical cancer operations, can be performed by endoscopy [1]. Laparoscopy is a minimally invasive technique, but studies on how these surgeries can be achieved less invasively are still ongoing. The decrement in the number of incisions and use of a single-incision technique are the focus of laparoscopic surgery. Many terms are used for single-incision techniques, such as single-port laparoscopy (SPL), single-port incision-less conventional equipment-utilizing surgery (SPICES), single-incision laparoscopic surgery (SILS), single-access endoscopic surgery (SAES), natural-orifice trans-umbilical surgery (NOTUS), one-port umbilical surgery (OPUS), and laparoendoscopic single-site surgery (LESS). It has been reported that LESS is feasible and safe for many gynecological procedures with better cosmetic results and less potential morbidity than multiple incisions [2–5]. However, LESS also has some well-known technical disadvantages that prevent this technique from being a standard technique, namely, crowding and clashing of instruments, loss of Fatih Şendağ, Professor Ege University Faculty of Medicine, Department of Obstetrics and Gynecology Ege Üniversitesi Tıp Fakültesi, Kadın Hastalıkları ve Doğum Anabilim Dalı TR–35100 Bornova/İzmir (Turkey) E-Mail fatih.sendag @ ege.edu.tr
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Key Words Hysterectomy · Laparoscopy · Robotic surgery · Single-port laparoscopy
Materials and Methods Patients who underwent robotic single-site total hysterectomy (RSS-TH) and laparoscopic single-site total hysterectomy (LESSTH) for benign gynecological indications in Ege University, Faculty of Medicine, Department of Obstetrics and Gynecology between January 2012 and December 2013 were included in this study. All operations using either the RSS-TH or LESS-TH technique during the study period were included for analysis. Data were collected retrospectively, and approval was obtained from our Institutional Review Board. Exclusion criteria for both surgical techniques were as follows: confirmed or suspicious gynecological malignancies, uterine size greater than 16 weeks gestational size on pelvic examination, history of endometriosis, and co-morbidities that are contraindications for laparoscopic surgery or prolonged Trendelenburg position, such as cardiopulmonary diseases. All surgical procedures were performed by the same surgeon (FS) experienced in advanced laparoscopic and robotic surgery. The surgical procedures were explained to all patients, and alternative techniques were discussed. All patients gave their informed consent. Surgical Technique for RSS-TH The da Vinci Single-Site robotic surgery platform (Intuitive, Sunnyvale, Calif., USA) and the da Vinci Single-Site Port were used for RSS-TH. This port included two curved cannulas for robotically controlled instruments and two straight cannulas for an 8.5 mm high definition endoscope and a 5 mm bed-side assistant surgeon port. The curved cannulas transmit interchangeable semirigid instruments that cross each other within the trocar so that the instrument that enters on the right becomes the left-sided operative instrument and vice versa. The da Vinci Si Surgical System automatically reassigns the Single-Site Platform instruments after docking so that the left hand of the surgeon will control the right arm of the robot and vice versa. Robotic instruments were 5 mm, non-wristed and semi-rigid, allowing them to be inserted through the curved cannulas. Although this new set-up was initially
2
Gynecol Obstet Invest DOI: 10.1159/000370000
launched without the inclusion of a bipolar grasping instrument, the bipolar grasper has been recently developed and is currently available. The Single-Site Port was inserted into the abdominal cavity after abdominal access was achieved via an open technique with a vertical intra-umbilical incision up to 2.5 cm in length. The optical port and laparoscope were then inserted and abdominopelvic visualization was achieved. Under direct visualization, two curved cannulas were then inserted. After the robot was docked centrally to the patient, a monopolar hook instrument and grasping instrument with or without the bipolar feature were inserted through robotic arm 2 and arm 1, respectively. Afterwards, the surgeon (FS) sat at the console; the instrument orientation was confirmed so that the left hand of the surgeon at the console controlled the left instrument (robotic arm 1) in the operative field despite the curved cannulas forming an opposite confirmation. Bilateral infundibulopelvic (IP) ligaments and round ligaments were sealed and transected with EnSeal (SurgRx Inc., Calif., USA) through the assistant port for the initial 12 operations. In contrast, IP and round ligaments were sealed and transected with bipolar and monopolar instrument, respectively, for the latter 12 cases. After developing a bladder flap, the uterine vessels were skeletonized with monopolar instruments. The uterine vessels were then sealed and transected in the same manner as IP ligaments. Afterwards, a circumferential colpotomy was performed using the monopolar instrument, the vaginal cuff was closed intracorporeally with intra-corporeal single stitches using da Vinci Single-Site Platform instruments in all cases. The RSS-TH surgical technique was described in detail in our previous reports [9–11]. Surgical Technique for LESS-TH The TriPort (Olympus America Inc., Pa., USA), multichannel single port, which allows three 5 mm laparoscopic instruments was used for the LESS-TH technique. The Endoeye 5 mm flexible laparoscope and Thunderbeat (Olympus America Inc., Pa., USA) were used for endoscopic visualization and sealing-transecting, respectively. Other instruments for grasping and suturing were the same rigid, straight instruments used for conventional multiport laparoscopy. After an intraumbilical vertical incision up to 2.5 mm was created, abdominal access was achieved and TriPort was inserted into the abdominal cavity. Bilateral IP and round ligaments were sealed and transected with Thunderbeat. Afterwards, a bladder flap was developed and the uterine vessels were skeletonized with the same instrument. A circumferential colpotomy was then performed using Thunderbeat again. At the final step, the vaginal cuff was closed laparoscopically with single stiches and an extracorporeal knot-tying technique. The LESS-TH surgical technique has been described in detail in a previous report [3]. Patient characteristics, including age, body mass index (BMI), length of hospital stay and history of previous abdominal surgery, were recorded. Perioperative data including estimated blood loss (EBL) (calculated by determining the difference between the volume of the fluid used for irrigation and suction at the end of the procedure), intraoperative complications, conversion to laparoscopy or laparotomy, post-hysterectomy uterine weight and operation time were recorded. Operation time was divided into subgroups as follows: set-up time (time between the start of the anesthetics and the first incision), port placement time (time between the first incision and the end of successful port placement),
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depth perception, ergonomic difficulties, loss of instrument triangulation, the need for advanced laparoscopic skills and a long learning curve [2, 3]. Recently, the robotic surgical system has been introduced to modern surgical practice. This system improved surgeon dexterity, visualization, ergonomics and surgical precision with the help of wristed instrumentation [6]. However, the robotic system required an increased number and size of ports. In accordance with a minimally invasive vision, LESS and robotic systems have been integrated, and single-site robotic surgery in gynecological practice has been reported [7–9]. The da Vinci Single-Site robotic surgery platform (Intuitive, Sunnyvale, CA, USA) was designed for this technique. The purpose of this study was to compare early surgical outcomes in patients who underwent total hysterectomy with LESS and the robotic single-site technique.
Table 1. Patient characteristics
Age, years Body mass index, kg/m2 Previous laparotomy, n (%)
RSS-TH (n = 24)
LESS-TH (n = 34)
p value
49.5 (40–61) 28.5 (21.7–34.2) 18 (75)
51.5 (44–67) 27.45 (22.5–34.5) 24 (70.6)
0.38 0.93 0.71
RSS-TH = Robotic single site total hysterectomy; LESS-TH = laparoendoscopic single site total hysterectomy.
Results
Twenty four patients who underwent RSS-TH and thirty four patients who underwent LESS-TH were included in this study. The median age and BMI in the RSSTH group were 49.5 and 28.5 kg/m2, respectively. In the LESS-TH group, the median age was 51.5 and the median BMI was 27.45 kg/m2. A total of 18 patients in the RSS-TH group and 24 patients in the LESS-TH group had a history of at least one previous abdominal surgery. There was no significant difference in age, BMI and history of previous abdominal surgery between the two groups, with p values of 0.38, 0.93 and 0.71, respectively (table 1). Single Port Total Hysterectomy: Robotic versus Laparoscopic
The estimated blood loss in the two different techniques is similar, with 22.5 ml in the RSS-TH group and 25 ml in the LESS-TH group (p = 0.38). None of the patients needed a blood transfusion. The operation time was significantly longer in the robotic surgery group, at 98.5 vs. 86 min (p = 0.013). Vaginal closure time was significantly higher in the laparoscopic surgery group (p = 0.011), while hysterectomy time was significantly longer in the robotic surgery group (p = 0.01) (table 2). There was no considerable difference between the two groups in setup time and port placement time (p = 0.072 and p = 0.35, respectively). The mean uterine weight was significantly higher in the robotic surgery group (p = 0.026). In the RSS-TH group, EnSeal (SurgRx Inc., Calif., USA) was used in 12 patients as a sealing device, while bipolar Single-Site Robotic instrument were used in 12 patients. Thunderbeat (Olympus America Inc., Pa., USA) was used for sealing in all patients in the LESS-TH group. There were no differences between the RSS-TH and LESS-TH group in postoperative pain scores (table 3). Similar rating scores were obtained in the LESS-TH group and the RSS-TH in overall satisfaction with surgery (9.0 ± 0.8 vs. 9.2 ± 0.4) and cosmetic appearance (8.9 ± 0.5 vs. 8.4 ± 0.7). Conversion to conventional laparoscopy or laparotomy did not occur in either group. There were no surgical complications in either group. The length of hospital stay after surgery was similar in both groups (p = 0.92). The mean follow-up after surgery was 9 months in the RSS-TH group and 12 months in the LESS-TH group. There were no surgical complications in either group during these periods.
Discussion
Laparoscopic surgery began with tubal ligations in the gynecological field in the 1970s [13]. Since then, developments in technology and techniques have made minimally invasive surgery the main goal of all surgeons. In gyneGynecol Obstet Invest DOI: 10.1159/000370000
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operation time (time between the skin incision and skin closure), hysterectomy time (time between the end of port placement and the beginning of vaginal closure), and vaginal cuff closure time (time between the insertion of the robotic single-site or laparoscopic needle holder to the abdomen and removal at the end of the closure). Postoperative pain was evaluated in all patients. One day before the operation, patients received instructions about the use of a patient-controlled analgesic device (APM; Abbott Laboratories, North Chicago, Ill., USA) and a visual analog scale (VAS) for pain. This scale consisted of an unmarked 10 cm line on which 0 cm represented no pain and 10 cm represented the worst pain imaginable. In the postoperative care unit, all patients had access to intravenous analgesia with morphine via a patient-controlled analgesic device. The settings of the device were as follows: loading dose of 0.05 mg/kg, bolus dose of 0.02 mg/kg, no continuous background infusion, lockout time of 15 min, and no 4 h maximum. Patients were given additional analgesic (diclofenac sodium, 75 mg intramuscularly (Voltaren R; Novartis Pharmaceuticals Corp., East Hanover, N.J., USA) when analgesia was inadequate (VAS score >3). Pain was assessed using VAS at 1, 2, 4, 6, 12 and 24 h after surgery. Patients were also requested to rate their overall satisfaction with the surgical procedure and cosmetic appearance on separate questionnaires [12]. The normality assumption was not met when the data were assessed with the Kolmogorov-Smirnov test, indicating that the data were nonparametric. Thus, the Mann-Whitney U test and Chisquare test were used for comparisons. The data were analyzed using the SPSS 20.0 software package (Chicago, Ill., USA). Statistical significance was defined as p < 0.05.
Table 2. Surgical outcomes
Estimated blood loss (EBL), ml Operation time, min Setup time Port placement time Docking time Console time Hysterectomy time Vaginal closure time Uterine weight, mg Conversion Complications Length of hospitalization after surgery, days
RSS-TH (n = 24)
LESS-TH (n = 34)
p value
22.5 (40–61) 98.5 (71–183) 22 (16–28) 8 (5–11) 5.5 (3–10) 74.5 (60–160) 53.5 (44–120) 21 (16–41) 192.5 (65–520) – – 1.6 (1–3)
25 (44–67) 86 (59–140) 24 (19–32) 7 (4–12) NA NA 43 (27–85) 26.5 (18–49) 117.5 (50–535) – – 1.8 (1–4)
0.38 0.013 0.072 0.35 NA NA 0.01 0.011 0.026 NA NA 0.92
RSS-TH = Robotic single site total hysterectomy; LESS-TH = laparoendoscopic single site total hysterectomy; NA = not applicable.
RSS-TH (n = 24) LESS-TH (n = 34) p value VASa 1st hour 6 (3–8) 2nd hour 6 (3–7) 4th hour 4 (2–6) 6th hour 3 (1–4) 12th hour 2 (0–3) 24th hour 1 (0–3) Total morphine consumption at 24 h, mgb 16.2 (9.7–26.1)
5.5 (3–7) 6 (2–7) 4 (1–6) 2 (1–4) 2 (0–4) 1 (0–2) 13.6 (10.2–26.8)
0.6 0.5 0.6 0.7 0.5 0.6 0.6
a
Values are given as median (range). b Values are given as median (range). RSS-TH = Robotic single site total hysterectomy; LESS-TH = laparoendoscopic single site total hysterectomy; VAS = visual analog scale.
cology today, almost all procedures can be performed endoscopically. Recently, a new method, single-site surgery was introduced in the field of minimally invasive surgery and initial reports have discussed the feasibility of this technique [3, 7–9]. Since the introduction of robotic surgery, laparoendoscopic single-site surgery has been integrated with robotics, and two means of single-site endoscopic surgery have emerged. In our study, we evaluated and compared the early surgical outcomes of these two techniques, robotic and laparoscopic single-site surgeries, in total hysterectomy operations. 4
Gynecol Obstet Invest DOI: 10.1159/000370000
Hysterectomy is one of the most common gynecologic surgeries and approximately 600,000 hysterectomies are performed annually in the United States; the rate of laparoscopic hysterectomies is increasing day by day worldwide [14]. With the minimally invasive approach, the single incision laparoscopic technique has both advantages over laparotomy, such as faster return to normal activities, shorter duration of hospital stay, and reduced pain, as well as advantages over multi-incision laparoscopic surgery, such as improved cosmetics and reduced risks related to trocar insertion, for example, vessel injury, hematoma and infection [15–17]. Because of these advantages, single-site hysterectomy seems feasible but has considerable limitations, especially technical limitations, as previously mentioned. To the best of our knowledge, the present study is the first study that compares robotic single-site ‘total’ hysterectomy with conventional laparoscopic single-site ‘total’ hysterectomy in benign cases. In this study, both groups were similar in demographic features, including age, BMI and history of previous abdominal surgery. In both groups, the operations were performed with non-wristed (curved and semi-rigid instruments for RSS-TH, and rigid and straight instruments for LESS-TH) instruments and the cuff suturing was performed laparoscopically. Setup time and port placement time were similar in both groups. Hysterectomy time was longer in the RSS-TH group, which may be due to the heavier or bigger uteruses in the RSS-TH group; the median uterine weight in the RSS-TH group was significantly higher than the LESS-TH group. Conversely, vaginal Akdemir/Yildirim/Zeybek/Karaman/ Sendag
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Table 3. Comparison of postoperative scores in different types of hysterectomy
closure time was longer in the LESS-TH group. One of the most important advantages of robotic surgery is the comfort of the surgeon during the operation. Although the same experienced surgeon used the same type of sutures and non-wristed instruments for suturing in both groups, vaginal closure took more time in the LESS-TH group. The main reason might be the fatigue of the surgeon and the crowding and clashing of instruments that occurs in the LESS-TH technique. It may also be caused by the loss of instrument triangulation, which is important for laparoscopic suturing and is one of the main challenges to suturing in LESS surgery. The total operation time was longer in the RSS-TH group than the LESS-TH group, at 98.5 min versus 88 min, respectively. Additional time for docking and longer hysterectomy time are the main factors that contributed to the longer total operation time in the robotic surgery group. The estimated blood loss, postoperative pain scores, and length of hospital stay after surgery were similar in both groups. Conversion to conventional multiport laparoscopy or laparotomy did not occur in either group. All patients had excellent postoperative recovery without early and/or late complications. Our results were comparable with other studies. Jung et al reported that median operative time was 100 min for the LESS-TH technique in thirty patients [16]. Puntambekar et al. reported that the mean operative time was 88 min for the same technique [18]. In RSS-TH, the results were similar. Nam et al reported seven cases in which the median operative time was 109 min (105–311 min) [19]. In the latter study, the authors used EndoWrist Technology in their operations. The most similar study to ours was reported by Fagotti et al. [20]. The authors compared robotic single-site hysterectomy and laparoendoscopic single-site hysterectomy in 19 and 38 early endometrial cancer patients, respectively. The median operative time was 90 min
in the robotic group and 107 min in the laparoscopic group with no significant differences between the two groups (p = 0.354). The authors performed cuff closure vaginally and did not perform lymphadenectomy on any of the patients. They claimed that the two procedures were comparable. The retrospective nature of the present study serves as a limitation. As a result of this study design, the uterine weights were not equal between the two groups. Thus, the larger uterine size could have caused the prolonged operation time observed in the RSS-TH group compared to the LESS-TH group. However, it is unique observation in the present study that the vaginal cuff closure was faster and more comfortable in RSS-TH than LESS-TH. Although single-site surgery seems feasible, it has prominent technical difficulties, such as internal and external clashing between the instruments and the surgeons’ hands, respectively. The da Vinci Single-Site robotic surgery platform (Intuitive, Sunnyvale, Calif., USA) was introduced to overcome these disadvantages of conventional single-port laparoscopy. The robotic surgery platform improved surgeon dexterity, surgical precision, visualization and, most importantly, ergonomics and vaginal cuff closure. However, in addition to these advantages, robotic single-site surgery is not significantly superior to conventional single site laparoscopy in terms of early surgical outcomes. In our experience, both techniques are feasible and safe, as previously reported [3, 20–23]; however, singlesite surgery still requires innovations such as wristed/articulated instruments to have better surgical outcomes.
Disclosure Statement The authors declare that there are no conflicts of interest.
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