Single-port Laparoscopic Hysterectomy versus Conventional Laparoscopic Hysterectomy: a Prospective Randomized Trial

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1 The Journal of International Medical Research 2012; 40: Single-port Laparoscopic Hysterectomy versus Conventional Laparoscopic Hysterectomy: a Prospective Randomized Trial M LI, Y HAN AND YC FENG Department of Minimally Invasive Gynaecology, Central Hospital of Fengxian District, Shanghai, China OBJECTIVE: To compare transumbilical single-port laparoscopic hysterectomy (TSPLH) with traditional four-port total laparoscopic hysterectomy (TLH). METHODS: Patients with benign uterine disease were assigned to receive either TSPLH (n = 52) or TLH (n = 56). Duration of surgery, intraoperative blood loss, conversion rate, time to first flatus, duration of immobilization, post - operative analgesia requirement, port site infection, port hernia, duration of hospital stay, postoperative fever rate and percentage patient satisfaction were recorded. RESULTS: TSPLH and TLH were both performed successfully. TSPLH was associated with significantly longer duration of surgery, shorter duration of immobilization, lower rate of port site infection and higher patient satisfaction than TLH. There were no other significant differences between the two groups. All subjects recovered fully and no postoperative complications occurred during a 6-month (minimum) follow-up period. CONCLUSIONS: TSPLH was found to be a feasible and safe approach for laparoscopic hysterectomy. KEY WORDS: TOTAL LAPAROSCOPIC HYSTERECTOMY; SINGLE-PORT ACCESS SYSTEM; SINGLE-PORT LAPAROSCOPIC HYSTERECTOMY Introduction Surgical procedures for hysterectomy have evolved tremendously over the last century, from laparotomy to laparoscopic surgery. The benefits of minimally invasive surgery, which are well known, include less pain, faster recovery and improved cosmetic results. 1 Standard laparoscopic hysterectomy has traditionally been performed with two 10-mm major manipulating trocars and two 5-mm ancillary trocars. The use of fewer and smaller ports has been shown to decrease incisional morbidity and improve cosmetic outcomes in laparoscopic surgery. 2 Since the first singleport laparoscopic surgery (SPLS) was reported in 1997, 3 it had been successfully used for nephrectomy, prostatectomy, cholecystectomy, splenectomy, gastrostomy tube placement and appendectomy. 4 6 SPLS represents the latest advance in minimally invasive surgery. Using flexible endoscopes and articulating instruments, the surgeon can perform complex procedures through a single 2-cm incision. In gynaecology, SPLS has been used 701

2 to perform oophorectomy, salpingectomy, bilateral tubal ligation, ovarian cystectomy, surgical treatment of ectopic pregnancy, and both total and partial hysterectomy. 7 9 The first case of transumbilical single-port laparoscopic hysterectomy (TSPLH) was reported in 2009, 10 but TSPLH technology has developed slowly due to technical and instrumental limitations. This study compared the safety and feasibility of TSPLH, using a commercially available single-port system (with one articulating grasper combined with other conventional laparoscopic instruments), with traditional four-port total laparoscopic hysterectomy (TLH) in patients undergoing hysterectomy for benign uterine disease. Patients and methods PATIENT POPULATION This prospective study included patients with benign uterine disease who underwent laparoscopic hysterectomy at the Department of Minimally Invasive Gynaecology, Central Hospital of Fengxian District, Shanghai, China, between February 2009 and September Patients were assigned to receive either TSPLH or TLH (control group) according to the sequence of their admission. Patients were required to be free from a history of heart disease, pneumonia, gastroenteritis and hepatitis, and to have a uterine size equivalent to < 12 gestational weeks. The Ethics Committee of the First Affiliated Hospital of Xinjiang Medical University, Xinjiang, China approved the study (reference number IACUC ). All patients provided written informed consent. DATA COLLECTION Demographic and clinical characteristics including age, body mass index (BMI), parity, previous caesarean section and previous lower abdominal or pelvic surgery, were recorded for all patients. Surgical outcome data regarding duration of surgery, blood loss (measured by recording the contents of the fluid extraction device), conversion rate (from TSPLH to TLH, or from TLH to open surgery), time to first flatus, duration of immobilization and postoperative analgesia were collected. The rates of port site infection and hernia, duration of postoperative hospital stay, postoperative fever rate and percentage patient satisfaction 11 were recorded during the perioperative period. All operations were performed by a single surgical team with the same senior surgeon (M.L.). Patients attended the Gynaecology Outpatient Clinic, Central Hospital of Fengxian District, Shanghai, China at 1, 3 and 6 months after surgery for gynaecological examination, pelvic ultrasound and routine blood testing, and all postoperative complaints were noted. Patients were followed-up for a minimum of 6 months, with additional examinations at 12 and 24 months. SURGICAL TECHNIQUES This study used the TriPort Access System (Olympus Medical Systems, Tokyo, Japan) with two flexible rings joined by a sleeve, and a three-channel port for the placement of instruments ranging in size from 5 to 10 mm (Figs 1 and 2). All patients in both groups were placed in the dorsal supine lithotomy position with their legs apart, with the senior surgeon located on the left side of the patient and the assistant surgeon on the right. All TSPLH procedures were performed with one articulating grasper (Tonglu Yida Medical Apparatus Factory, Tonglu, China) and other conventional laparoscopic instruments such as bipolar forceps, unipolar hooks, suction apparatus, 702

3 FIGURE 1: Intraoperative view of the TriPort Access System (Olympus Medical Systems Corp.) in transumbilical single-port laparoscopic hysterectomy for benign uterine disease FIGURE 2: Intraoperative view of an articulating grasper combined with traditional bipolar forceps in transumbilical single-port laparoscopic hysterectomy for benign uterine disease using the TriPort Access System (Olympus Medical Systems Corp.) absorbable clips, a 10-mm laparoscope and an ultrasonic scalpel (all from Olympus Medical Systems). A 2-cm intraumbilical incision was made for tri-port access, the triport device was inserted into the umbilicus and a carbon dioxide pneumoperitoneum was established with a pressure of 12 mmhg. A 10-mm laparoscope was inserted into the abdominal cavity through the major manipulating port. The uterus was removed through a vaginal incision and the vaginal cuff was sutured via the vagina. 703

4 All TLH procedures were performed via 2- cm incisions using conventional TLH techniques and laparoscopic instruments, including 5- and 10-mm trocars (Olympus Medical Systems) and a carbon dioxide pneumoperitoneum of mmhg. The uterus was removed through the vaginal incision and suturing was performed via the vagina. STATISTICAL ANALYSES Data were recorded as mean ± SD (range), median (range) or number (percentage) of patients. Differences between the two groups were analysed using the χ 2 -test. Statistical analyses were performed using SPSS version 11.0 (SPSS Inc., Chicago, IL, USA) for Windows. A P-value < 0.05 was considered statistically significant. Results A total of 108 patients with benign uterine disease were included in the study. The TSPLH group (n = 52) included 27 patients with uterine myoma and 25 with adenomyoma; the TLH (control) group (n = 56) included 33 patients with uterine myoma and 23 with adenomyoma. Uterine size was < 12 gestational weeks in all patients (uterine weight range g). There were no significant differences between the two surgical groups in terms of age, uterine size, BMI, parity, previous caesarean section and lower abdominal or pelvic surgery (Table 1). The minimum duration of follow up was 6 months (median 17 months; range 6 24 months). Surgical outcomes are shown in Table 2. There were no significant between group differences in blood loss, conversion rate, time to first flatus, postoperative analgesia rate, port hernia, duration of hospital stay or postoperative fever rate. The median duration of immobilization was significantly shorter (P = 0.01), the rate of port site infection significantly lower (P = 0.03), the patient satisfaction score significantly higher (P < 0.01) and the duration of surgery significantly longer (P < 0.01) in the TSPLH group compared with the TLH group. All patients recovered from the operation and no complications occurred during the followup period. The mean duration of surgery was significantly shorter for the final 27 patients to undergo TSPLH compared with the first 25 patients (P = 0.02; Table 3). The mean patient satisfaction score was also significantly higher in the final 27 patients compared with the first 25 patients (P = 0.04). TABLE 1: Demographic and clinical characteristics of the patients who underwent either transumbilical single-port laparoscopic hysterectomy (TSPLH) or traditional four-port total laparoscopic hysterectomy (TLH) for benign uterine disease TSPLH TLH Characteristic n = 52 n = 56 Age, years 46 (36 61) 48 (37 65) Body mass index, kg/m 2 24 (22 27) 24 (22 28) Parity 2 (0 4) 2 (1 3) Previous caesarean section 11 (27.5) 13 (31.0) Previous lower abdominal or pelvic surgery 7 (17.5) 8 (19.0) Data presented as median (range) or n (%) patients. No statistically significant between-group differences (P 0.05, χ 2 -test). 704

5 TABLE 2: Surgical outcomes of patients who underwent either transumbilical single-port laparoscopic hysterectomy (TSPLH) or traditional four-port total laparoscopic hysterectomy (TLH) for benign uterine disease TSPLH TLH Statistical Parameter n = 52 n = 56 significance a Duration of surgery, min ± ± P < 0.01 ( ) ( ) Blood loss, ml ± ± NS ( ) ( ) Conversion rate 1 (1.92) 2 (3.57) NS Time to first flatus, h ± ± 4.68 NS ( ) ( ) Duration of immobilization, h ± ± 2.35 P = 0.01 ( ) ( ) Postoperative analgesia 4 (7.69) 6 (10.71) NS Port site infection 1 (1.92) 5 (8.93) P = 0.03 Port hernia 0 (0) 0 (0) Postoperative fever 12 (23.07) 14 (25.00) NS Postoperative hospital stay, days 5.02 ± ± 1.01 NS ( ) ( ) Patient satisfaction score, % ± ± 6.09 P < 0.01 ( ) ( ) Data presented as mean ± SD (range) or n (%) patients. a χ 2 -test. NS, not statistically significant (P 0.05). Discussion Recent advances in laparoscopic equipment and improvements in surgical skills have further enhanced the advantages of laparoscopic surgery over open surgery. Many surgeons have attempted to reduce abdominal wall trauma by decreasing either the size of the ports used or the number of trocars. 12 A TABLE 3: Surgical outcomes of the first 25 patients who underwent transumbilical single-port laparoscopic hysterectomy (TSPLH) for benign uterine disease, compared with the next 27 patients who underwent the same procedure Statistical Parameter First 25 patients Next 27 patients significance a Duration of surgery, min ± ± P = 0.02 ( ) ( ) Postoperative hospital stay, days 6.00 ± ± 1.11 NS ( ) ( ) Patient satisfaction score, % ± ± 6.52 P = 0.04 ( ) ( ) Data presented as mean ± SD (range). a χ 2 -test NS, not statistically significant (P 0.05). 705

6 limited number of reports were published in the early years of laparoscopic surgery and many surgeons did not think that such a difficult operation would be beneficial for patients, other than in reducing scarring. 13,14 Total laparoscopic thyroidectomy and cholecystectomy have since become widely performed in many medical centres, and the concept of a minimally invasive, aesthetic procedure has been accepted by many surgeons and welcomed by patients. 15,16 Improvements in laparoscopic technology and instruments have resulted in more surgeons being willing to attempt this approach. 17,18 New instrumentation and strategies have alleviated some of the challenges of performing laparoscopy through a single abdominal incision for a range of gynaecological procedures. 19,20 Gynaecologists began to explore TSPLH 21,22 and developed the single-port technique. 23,24 An inventive technique for SPLS using standard instrumentation involved fitting a selfretaining ring retractor with a surgical glove, in which three of the fingers had been removed and replaced with trocars. 25 Suturing is a very common procedure in gynaecological surgery and can be challenging to perform through a single port. It is possible to perform standard suturing with both intracorporeal and extracorporeal methods when endoscopic suturing is required. The latest instruments are designed to dissect, cauterize and cut, thereby decreasing the number of instrument exchanges that are needed. Concurrent manipulations are necessary to operate efficiently and to avoid having the apparatus suddenly disappear from view. The surgeon requires considerable experience with laparoscopic operations to overcome these difficulties, although these can be addressed to some extent by the use of advanced instruments. Such instruments are very expensive 26 and unaffordable to surgeons in developing countries. The use of bidirectional self-retaining sutures was avoided in the current study by suturing the cuff via the vagina. Instrument interaction during surgery is a crucial problem that needs to be resolved, although it can be overcome by the surgeon s skill. Only one patient in the TSPLH group was converted to TLH in the present study (due to severe inflammatory adhesion); TSPLH was therefore feasible in practice. No postoperative complications (such as incisional hernia) occurred in either group, suggesting that TSPLH had the same level of safety as TLH. As surgical experience increases and instruments are developed, the time required for TSPLH is likely to become as short as that for TLH. The TSPLH group reported a higher patient satisfaction score than the TLH group in the present study, indicating that TSPLH was attractive to most patients. The potential benefits of single-incision laparoscopic access include decreased pain, a shorter recovery period, lower morbidity, reduced cost and superior cosmetic outcome. 27 Careful case selection and a low threshold of conversion to conventional laparoscopic surgery are essential. Multicentre, randomized, prospective studies are needed to compare short- and long-term outcome measures following SPLS against those of conventional laparoscopic surgery. TSPLH was feasible and safe in this study, although it was more time consuming than conventional laparoscopy. The shorter duration of surgery in the final 27 TSPLH patients, compared with the first 25 patients, indicated that operation times decreased as the techniques were perfected. Further clinical investigations should elucidate the efficacy of SPLS. 13 Although TSPLH is welcomed by patients who have concerns about the cosmetic effects of surgery, larger randomized 706

7 controlled trials are needed to assess the safety and efficacy of this technique. 28 There is a need for large-scale, prospective randomized studies with long-term follow-up to confirm these initial findings. The TSPLN procedure with vaginal suturing of the cuff used in this study was feasible, simple, had few postoperative complications and was verified as being completely successful. Acknowledgements We thank Dr Hongbing Wang (Department of Cardiac Surgery, Central Hospital of Fengxian District, Shanghai, China) for his help with the review of the final manuscript. This study was supported by grants from the Sixth People s Hospital of Shanghai Clinical Foundational Research Fund of 2010, and a Hospital Research Grant from the Sixth People s Hospital of Shanghai Medicine Fund of Conflicts of interest The authors had no conflicts of interest to declare in relation to this article. Received for publication 7 November 2011 Accepted subject to revision 27 November 2011 Revised accepted 9 February 2012 Copyright 2012 Field House Publishing LLP References 1 Medeiros LR, Rosa DD, Bozzetti MC, et al: Laparoscopy versus laparotomy for benign ovarian tumour. Cochrane Database Syst Rev 2009; 2: CD Fader AN, Levinson KL, Gunderson CC, et al: Laparoendoscopic single-site surgery in gynaecology: a new frontier in minimally invasive surgery. J Minim Access Surg 2011; 7: Navarra G, Pozza E, Occhionorelli S, et al: Onewound laparoscopic cholecystectomy. Br J Surg 1997; 84: Froghi F, Sodergren MH, Darzi A, et al: Singleincision laparoscopic surgery (SILS) in general surgery: a review of current practice. Surg Laparosc Endosc Percutan Tech 2010; 20: Tacchino R, Greco F, Matera D, et al: Singleincision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc 2009; 23: Saber AA, El-Ghazaly TH: Early experience with SILS port laparoscopic sleeve gastrectomy. Surg Laparosc Endosc Percutan Tech 2009; 19: Kim YW: Single port transumbilical myomectomy and ovarian cystectomy. J Minim Invasive Gynecol 2009; 16: Lim MC, Kim TJ, Kang S, et al: Embryonic natural orifice transumbilical endoscopic surgery (E-NOTES) for adnexal tumors. Surg Endosc 2009; 23: Escobar PF, Starks DC, Fader AN, et al: Singleport risk-reducing salpingo-oophorectomy with and without hysterectomy: surgical outcomes and learning curve analysis. Gynecol Oncol 2010; 119: Langebrekke A, Qvigstad E: Total laparoscopic hysterectomy with single-port access without vaginal surgery. J Minim Invasive Gynecol 2009; 16: Tomlinson JS, Ko CY: Patient satisfaction: an increasingly important measure of quality. Ann Surg Oncol 2006; 13: Tsai AY, Selzer DJ: Single-port laparoscopic surgery. Adv Surg 2010; 44: Ahmed K, Wang TT, Patel VM, et al: The role of single-incision laparoscopic surgery in abdominal and pelvic surgery: a systematic review. Surg Endosc 2011; 25: Atallah S, Albert M, Larach S, et al: Transanal minimally invasive surgery: a giant leap forward. Surg Endosc 2010; 24: Snissarenko EP, Kim GH, Simental AA Jr, et al: Minimally invasive video-assisted thyroidectomy: a retrospective study over two years of experience. Otolaryngol Head Neck Surg 2009; 141: Brody F, Vaziri K, Kasza J, et al: Single incision laparoscopic cholecystectomy. J Am Coll Surg 2010; 210: e9 e Romanelli JR, Roshek TB 3rd, Lynn DC, et al: Single-port laparoscopic cholecystectomy: initial experience. Surg Endosc 2010; 24: Lee SY, Kim YT, Park HY, et al: Initial experience with laparoendoscopic single-site surgery by use of a homemade transumbilical port in urology. Korean J Urol 2010; 51: Jackson TR, Einarsson JI: Single-incision laparoscopic myomectomy. J Minim Access Surg 2011; 7: Escobar PF, Fader AN, Paraiso MF, et al: Roboticassisted laparoendoscopic single-site surgery in gynecology: initial report and technique. J 707

8 Minim Invasive Gynecol 2009; 16: Nam EJ, Kim SW, Lee M, et al: Robotic singleport transumbilical total hysterectomy: a pilot study. J Gynecol Oncol 2011; 22: Park HS, Kim TJ, Song T, et al: Single-port access (SPA) laparoscopic surgery in gynecology: a surgeon s experience with an initial 200 cases. Eur J Obstet Gynecol Reprod Biol 2011; 154: Atkin RP, Nimaroff ML, Bhavsar V, et al: Applying single-incision laparoscopic surgery to gyn practice: what s involved. OBG Management 2011; 23: Elazary R, Khalaileh A, Zamir G, et al: Singletrocar cholecystectomy using a flexible endoscope and articulating laparoscopic instruments: a bridge to NOTES or the final form? Surg Endosc 2009; 23: Jeon HG, Jeong W, Oh CK, et al: Initial experience with 50 laparoendoscopic single site surgeries using a homemade, single port device at a single center. J Urol 2010; 183: Hirano Y, Watanabe T, Uchida T, et al: Singleincision laparoscopic cholecystectomy: single institution experience and literature review. World J Gastroenterol 2010; 16: Jung YW, Kim YT, Lee DW, et al: The feasibility of scarless single-port transumbilical total laparoscopic hysterectomy: initial clinical experience. Surg Endosc 2010; 24: Koyanagi T, Motomura S: Transumbilical single-incision laparoscopic surgery: application to laparoscopically assisted vaginal hysterectomy. Arch Gynecol Obstet 2011; 283: Author s address for correspondence Dr Ying Han Department of Minimally Invasive Gynaecology, Central Hospital of Fengxian District, No Nanfeng Road, Nanqiao Town, Fengxian District, Shanghai , China. xjhy0519@163.com 708