Endoscopy · Reprint
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Reprint Volume 39 · 2007 Georg Thieme Verlag KG Reprint with the permission of the publishers only
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Endoscopy
This is a copy of the author’s personal reprint
Official Organ of the European Society of Gastrointestinal Endoscopy (ESGE) and affiliated societies
572
Original article
NOTES transvaginal video-assisted cholecystectomy: first series
A. Cardoso Ramos, A. Murakami, M. Galv¼o Neto, M. Santana Galv¼o, A. C. Souza Silva, E. Gonzalo Canseco, Y. Moyses
Institution
Gastro Obeso Center, S¼o Paulo, Brazil
submitted 20 April 2008 accepted after revision 8 June 2008
Background and study aims: Extensive research has been conducted to develop natural-orifice transluminal endoscopic surgery (NOTES) as a new approach to less invasive surgery. Our aim is to present the technique and initial prospective results of a transvaginal video-assisted laparoscopic approach to NOTES cholecystectomy in order to perform minimally invasive surgery without visible scars. Patients and methods: From July 2007 to March 2008, 32 women underwent transvaginal videoassisted laparoscopic cholecystectomy using a transvaginal 10-mm 45 8 rigid bariatric optic through a 12-mm bariatric trocar and two abdominal trocars (2-mm and 5-mm). Data on the history, surgical time, complications, and recovery were recorded prospectively in each case.
Results: Mean age was 33 years (range 22 – 47 years); mean body mass index was 29 (range 20 – 42). Mean operative time was 38 minutes (range 18 – 50 minutes). Patients were discharged 6 hours after the procedure without the need for pain medication in the following days and returned to normal working activities within 24 hours of the procedure. Conclusions: Transvaginal video-assisted NOTES cholecystectomy seems to be an efficient and safe approach to minimally invasive surgery, providing patients with a comfortable recovery with virtually no abdominal scars as a bridge to exclusively NOTES procedures.
Introduction
dominal cavity to perform surgery without scars [11]. In order to ensure a safe approach to the abdominal cavity, several accesses to performing natural-orifice transluminal endoscopic surgery (NOTES) have been tested in animal models [12]. Transgastric NOTES appendectomies [13] and transvaginal NOTES cholecystectomies have been reported in animals [14] and in humans [15 – 18]. Some authors have proposed using a standard laparoscope transvaginally in order to overcome the problems of operating the flexible scope inside the abdominal cavity to perform cholecystectomies without visible scars as a bridge to developing human NOTES procedures [19]. Our purpose is to present a transvaginal video-assisted laparoscopic approach to NOTES cholecystectomy, to discuss technical aspects and report initial results of this first series.
Bibliography DOI 10.1055/s-2008-1077398 Endoscopy 2008; 40: 572–575 Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author A. H. F. Murakami, MD Rua Barata Ribeiro, 237 cj. 83/84 – Cerqueira Cesar S¼o Paulo – SP CEP: 01308–000 Brazil Fax: +55-11-32111200
[email protected] [email protected]
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This is a copy of the author’s personal reprint
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Authors
Gallbladder stones are one of the most common surgical diseases affecting the world population, chiefly because its risk factors such as obesity are very common in modern society [1]. The open cholecystectomy technique was first performed late in the nineteenth century [2] and developed in the twentieth century as described by O’Conor in 1922 [3]. Later, advances in surgical technique led to an urge to minimize the surgical approach to less invasive surgery. In 1982 Dubois and Berthelot proposed the minicholecystectomy as an open approach to cholecystectomy by an abdominal incision smaller than 6 cm [4]; they were later followed by others [5, 6]. Since the first laparoscopic cholecystectomy was reported by Mühe in 1985 [7] and Mouret et al. in 1987 [8, 9], laparoscopy has become the procedure of choice for treating symptomatic biliary lithiasis [10]. In recent years, extensive research has been conducted to overcome laparoscopy by using a flexible scope via a transluminal access to the ab-
Cardoso Ramos A et al. NOTES transvaginal video-assisted cholecystectomy … Endoscopy 2008; 40: 572 – 575
Original article
Patients and methods
Fig. 1 Position of trocars: 2-mm on the right flank, 5-mm intraumbilical, 12-mm transvaginal.
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2 mm right flank
5 mm intraumbilical
12 mm transvaginal
max 5 mm Endoclips applier, Ethicon Endo-Surgery, Cincinnati, Ohio, USA). In three cases we performed intraoperative cholangiography using a 22-gauge peridural catheter inserted in the umbilical incision and then through the cystic duct under continuous fluoroscopic guidance. After sectioning of the cystic artery and cystic duct, a cautious retrograde cholecystectomy was performed using the harmonic scalpel. Once the gallbladder was completely removed from the liver it was held still by the left-hand 2-mm grasper. The 5-mm optic was inserted through the umbilical port to guide optic retrieval and the insertion of a 5-mm grasper through the vaginal trocar. Under direct vision, the gallbladder was grasped and removed from the abdominal cavity through the posterior fornix " Fig. 2). Hemostasis of the liver and artery and duct clips (l were reviewed via the 5-mm optic. After that, residual gas from the pneumoperitoneum was removed. Suturing of the vaginal opening was performed transvaginally using absorbable thread (Vicryl 2 – 0). Postoperative analgesia was obtained with an intravenous nonsteroidal anti-inflammatory drug and dipyrone. At the time of discharge all patients were advised to take a combination of dipyrone, promethazine, and adiphenine (Lisador) if they had pain at home, and to avoid sexual activity for the following 2 weeks. Patients were advised to return to their routine life activities the day after hospital discharge. Follow-up visits were scheduled for postoperative days 7 and 30 and then every 2 months throughout the first year. Patients were asked how many times they needed to take pain medication and answered a specific questionnaire addressing dyspareunia issues, designed by a fellow gynecologist, on the visit on postoperative day 30.
This is a copy of the author’s personal reprint
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Fig. 2 Transvaginal retrieval of the gallbladder.
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From July 2007 to March 2008, 86 patients were selected for gallbladder surgery at our service. Of these, 21 patients (24 %) had symptomatic cholelithiasis and 65 (76 %) had gallbladder stones diagnosed during follow-up after bariatric surgery and were scheduled to undergo cholecystectomy because they had a bypassed stomach and risked developing lithiasis in the main biliary duct. Transvaginal video-assisted laparoscopic cholecystectomy (TVG-chole) was offered to all female patients within this group (60 patients, 70 %) as an alternative to laparoscopic cholecystectomy (LAP-chole) in a controlled protocol. There were no exclusion criteria relating to age, morbid conditions, or previous operations. Thirty-two women (53 %) accepted TVGchole. They were informed of all the risks and benefits related to the transvaginal access and about the experience of the authors with this access in the experimental setting [20]. All of them signed an informed consent form in order to be included in the study, and the procedure was approved by the hospital’s ethics committee and institutional review board. The procedures were performed by a single surgeon in an operating room suitable for advanced laparoscopic procedures. As part of the study, all patients underwent a gynecological examination by a specialist prior to procedure. Patients were operated on in the lithotomy position. The abdomen was prepared antiseptically using a chlorhexidine solution and the vagina with a topical iodine solution. The surgeon stood in between the patient’s legs; the first and second assistants were on the left and right side of the patient respectively. In this setting, we used two laparoscopic sets, one for the abdominal and the other for the transvaginal laparoscopic camera. The procedure started with a Verres puncture through an incision in the umbilicus in order to avoid a visible scar. A 12mmHg pneumoperitoneum was then induced. A 5-mm trocar was inserted and a 5-mm 30 8 laparoscopic optic used to inspect the abdominal cavity. In order to avoid the risk of injuring pelvic organs, we started with a thorough examination of the pelvis, looking for adhesions that might prohibit the transvaginal culde-sac puncture. In one patient who had had a hysterectomy, we found too many adhesions within the sigmoid colon and the small bowel, obliterating the pouch of Douglas, so we converted to laparoscopic cholecystectomy. Under intra-abdominal laparoscopic direct guidance, the uterus was retracted anteriorly using an intrauterine manipulator, and a 12-mm bariatric trocar was placed in the posterior vaginal fornix to attain the peritoneal cavity. Later, this trocar was used as the camera port for the procedure, using a 10-mm 45 8 rigid bariatric laparoscopic optic. In order to develop a safe technique for vaginal puncture, the first ten procedures were supervised by a fellow gynecologist experienced in the treatment of deep endometriosis, respecting a triangular zone known to be avascular and without innervation in between the two uterosacral ligaments. In addition, a 2-mm trocar was inserted at the right abdominal flank to retract the gallbladder (surgeon’s left hand). The abdominal optic was retrieved from the umbilical port, which was used as the working port for dissection and clipping " Fig. 1). (surgeon’s right hand) (l Calot’s triangle was dissected using a laparoscopic 5-mm Harmonic scalpel (Harmonic ACE 5 mm shears, Ethicon Endo-Surgery, Cincinnati, Ohio, USA). The cystic artery was ligated and sectioned with the Harmonic scalpel and the cystic duct ligated and sectioned in between 5-mm laparoscopic clips (M-L Liga-
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Cardoso Ramos A et al. NOTES transvaginal video-assisted cholecystectomy … Endoscopy 2008; 40: 572 – 575
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Original article
Results !
Fig. 3
Intraoperative cholangiography. No signs of duct stones.
All patients were discharged 6 hours after the procedure without complaints relating to the transvaginal instrumentation. During the visit on postoperative day 7, patients were asked about their need for pain medication, but all of them had had a good recovery without the need for analgesics. We observed no abdominal or vaginal complications. On the subsequent visit on postoperative day 30, patients responded to a questionnaire on dyspareunia, and none of them had suffered from it. In addition, they underwent a gynecological examination by our gynecologist, who found no signs of sequelae from the vaginal puncture. All patients were able to return to normal daily activities within 24 hours after the procedure and had been symptom-free for a mean follow-up period of 5 months (range 1 – 8 months). There were no deaths.
Discussion !
After its first description by Mouret et al. [8, 9] in 1987, laparoscopic cholecystectomy has rapidly developed as the procedure of choice for gallbladder surgery and was the first step in the development and acceptance of laparoscopic surgery. With the advantages of the minimally invasive approach to the abdominal cavity of shortened hospital stays and minimum operative trauma, laparoscopy set the trend for modern surgery. During recent years research in surgery appointed endoscopy as an alternative to less invasive surgery avoiding abdominal scars. Since then an extensive literature has been produced to address its development, risks, and benefits [11]. Although an endoscopic transluminal approach to the peritoneal cavity seems a relative simple and rational way to undertake abdominal surgery, much concern has arisen about breaking the barrier of a healthy organ in terms of safe closure and the risk of infection. Another dilemma faced by endoscopic surgeons was the limitations on the instruments used to carry out endoscopic
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This is a copy of the author’s personal reprint
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Over an 8-month period, 32 women were underwent TVG-chole. Mean age was 33 years (range 22 – 47 years); mean body mass index was 29 (range 20 – 42). Two women (6 %) were morbidly obese. Operating time ranged from 18 to 50 minutes (mean 38 minutes). There were three cases (9 %) in which intraoperative cholangiography was performed and showed no signs of common " Fig. 3). There was one conversion (3 %) to bile duct stones (l LAP-chole in this series, in a patient who had had a previous hysterectomy and in whom initial laparoscopy revealed adhesions within the pelvic organs, prohibiting the transvaginal puncture.
surgery, and the restrictions of movement and the stability of a flexible scope inside the peritoneal cavity [11 – 13]. The transvaginal access to the abdominal cavity has been widely used, mostly by gynecologists, to perform resection of intraperitoneal organs without complications and diagnostic and interventional procedures such as fertiloscopy and transvaginal hydrolaparoscopy. In 2001 Gordts et al. [21] reported the results of a multinational retrospective survey on fertiloscopy and transvaginal hydrolaparoscopy, covering 3667 procedures, to evaluate the prevalence of bowel injury. The overall bowel injury rate was 0.65 %, decreasing from 1.25 % to 0.25 % when operators had experience of more than 50 procedures. Later, in 2005, Gordts et al. [22] reported a personal series of 663 transvaginal laparoscopies with five inadvertent punctures of the posterior wall of the uterus, one bleeding from the vaginal insertion point, and five (0.7 %) needle perforations of the rectum without consequences. They also postulated that the transvaginal route is of particular interest for some procedures such as the treatment of ovarian endometriosis and polycystic ovaries. Of note in the TVG-chole procedure was that the initial transumbilical laparoscopy inspected and guided the transvaginal puncture, diagnosing obliteration of the pouch of Douglas that would prohibit safe access to the abdominal cavity and orientating the insertion of the trocar in between the uterosacral ligaments, avoiding bowel lesions. In addition, some surgeons have combined laparoscopic abdominal surgery with transvaginal specimen retrieval [19]. Some groups have advocated a transvaginal approach for a NOTES procedure as a safe access because there is a minimal risk of infection and safe closure. Transvaginal endoscopic and endoscopy-assisted cholecystectomies have been described in experimental animals and human protocols [14 – 18]. Of note, Bessler et al. [14] have developed an animal model to perform a laparoscopically assisted transvaginal endoscopic cholecystectomy. Zornig et al. [19] have recently described the use of both a laparoscopic optic and a grasper inserted through the posterior vaginal fornix to perform cholecystectomy, reporting a short operative time that outweighs the initial difficulties of instrumentation of abdominal viscera and space orientation inside the peritoneal cavity with a flexible scope. An early original report by Palanivelu et al. [23] proposed a transumbilical approach to hybrid NOTES cholecystectomy using a flexible double-channel scope through a 15-mm transumbilical trocar and a 2-mm left hypochondrium trocar for gallbladder retraction and maintenance of pneumoperitoneum. They reported a feasibility study with 10 well-selected patients and found a mean operating time of 148 minutes and a conversion rate of 40 % (4 patients). Conversions were due to uncontrolled hemorrhage, difficulty in identifying the cystic duct, and artery and bile leak. The authors regarded these results as representing an initial learning curve and problems in orientation and triangulation inherent to endoscopic surgery. Natural-scar surgery through the umbilicus avoids the risks relating to safe closure and infection and brings the benefits of surgery without a visible scar to both men and women. These results accord with the reports in the literature and with our experience that to perform a purely NOTES procedure that would be equivalent to the standard laparoscopic surgery would require too much development in the field of flexible endoscopy instrumentation. Our NOTES experience started in an experimental environment with the transgastric approach to NOTES cholecystectomy, salpingectomy, and oophorectomy in a porcine model which was
Cardoso Ramos A et al. NOTES transvaginal video-assisted cholecystectomy … Endoscopy 2008; 40: 572 – 575
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1 Graewin SJ, Tran , KQ , Naggert JK et al. Diminished gallbladder motility in rotund leptin-resistant obese mice. HPB (Oxford) 2005; 7: 139 – 143 2 Burden VG. The clinical behavior of the normal and the diseased gall bladder. Am J Surg 1927; 3: 556 – 563 3 O’Conor J. The surgical treatment of cholelithiasis, cholecystectomy and choledochotomy: continuous out-door treatment. Ann Surg 1922; 76: 201 – 204 4 Dubois F, Barthelot B. Cholecystectomie par mini-laparotomie. Nouv Presse Med 1982; 11: 1139 – 1141 5 Kopelman D, Schein M, Assalia A et al. Technical aspects of minicholecystectomy. J Am Coll Surg 1994; 178: 624 – 625 6 Oyogoa SO, Komenaka IA, Ilkhani R et al. Mini-laparotomy cholecystectomy in the era of laparoscopic cholecystectomy: a communitybased hospital perspective. Am Surg 2003; 69: 604 – 607 7 Litynski G. Erich Mühe and the rejection of laparoscopic cholecystectomy (1985): a surgeon ahead of his time. JSLS 1998; 2: 341 – 346 8 Mouret P. From the first laparoscopic cholecystectomy to the frontiers of laparoscopic surgery: the future perspectives. Dig Surg 1991; 8: 124 – 125 9 Cuschieri A, Dubois F, Mouriel J et al. The European experience with laparoscopic cholecystectomy. Am J Surg 1991; 161: 385 – 387 10 Duca S, B¼l¼ O, Al-Hajjar N et al. Laparoscopic cholecystectomy: incidents and complications. A retrospective analysis of 9542 consecutive laparoscopic operations. HPB (Oxford) 2003; 5: 152 – 158 11 Wagh MS, Thompson CC. Surgery insight: natural orifice transluminal endoscopic surgery – an analysis of work to date. Nat Clin Pract Gastroenterol Hepatol 2007; 4: 386 – 392 12 Flora ED, Wilson TG, Martin IJ et al. 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 13 Rao GV, Reddy DN, Banerjee R. NOTES: human experience. Gastrointest Endosc Clin North Am 2008; 18: 361 – 370 14 Bessler M, Stevens PD, Milone L et al. Transvaginal laparoscopic cholecystectomy: laparoscopically assisted. Surg Endosc 2008; [Epub ahead of print]: 15 Zorrón R, Filgueiras M, Maggioni LC et al. NOTES transvaginal cholecystectomy: report of the first case. Surg Innov 2007; 14: 279 – 283 16 Bessler M, Stevens PD, Milone L et al. Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery. Gastrointest Endosc 2007; 66: 1243 – 1245 17 Branco Filho AJ, Noda RW, Kondo W et al. Initial experience with hybrid transvaginal cholecystectomy. Gastrointest Endosc 2007; 66: 1245 – 1248 18 Marescaux J, Dallemagne B, Perretta S et al. Surgery without scars. Report of transluminal cholecystectomy in a human being. Arch Surg 2007; 142: 823 – 827 19 Zornig C, Emmermann A, von Waldenfels HA et al. Laparoscopic cholecystectomy without visible scar: combined transvaginal and transumbilical approach. Endoscopy 2007; 39: 913 – 915 20 Marchesini JC, Baretta G, Mottin CC et al. Hybrid transvaginal sleeve gastrectomy in a porcine model. Poster 227, 2008 Scientific session of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Philadelphia, Pennsylvania, USA, 9–12 April 2008. Surg Endosc 2008; 22: 191 – 293 21 Gordts S, Watrelot A, Campo R et al. Risk and outcome of bowel injury during transvaginal pelvic endoscopy. Fertil Steril 2001; 76: 1238 – 1241 22 Gordts S, Puttemans P, Gordts Sy et al. Transvaginal laparoscopy. Best Pract Res Clin Obstet Gynaecol 2005; 19: 757 – 767 23 Palanivelu C, Rajan PS, Rangarajan M et al. Transumbilical flexible endoscopic cholecystectomy in humans: first feasibility study using a hybrid technique. Endoscopy 2008; 40: 428 – 431
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Competing interests: Yes. Almino Cardoso Ramos and Manoel Galv¼o Neto are consultants for and receive meeting travel expenses from Ethicon Endo-Surgery.
References
This is a copy of the author’s personal reprint
presented as a video oral presentation at SAGES 2007. Later we developed a porcine animal model for a hybrid transvaginal sleeve gastrectomy presented as a poster at SAGES 2008 [20]. We have learned that the development of a totally NOTES procedure was dependent on the creation of specific instruments for stable navigation and instrumentation inside the peritoneal cavity. The transvaginal access grew as a safe and reproducible approach to pure and hybrid NOTES procedures as reported in the recent literature [14 – 19]. Combining our experience as a highvolume bariatric surgery service performing over 1000 bariatric procedures a year, and with a high incidence of cholecystectomy indications in our postoperative population (over 100 per year), we hypothesized that using a 12-mm bariatric trocar to operate a laparoscopic rigid optic through the vagina in order to assist a laparoscopic cholecystectomy using a 5-mm umbilical port and a 2-mm right-flank port could mostly avoid visible scars and allow performance of a safe hybrid NOTES procedure. No problems related to the vaginal incision were observed, nor any with the initial Verres puncture. Previous abdominal surgery such as cesarean sections or bariatric procedures did not restrict this approach; only in one case did a previous hysterectomy prohibit the insertion of the vaginal trocar due to adhesions. Initial concern about the feasibility of TVG-chole in the morbidly obese was not confirmed as two patients in this series (6 %) had a BMI over 40 but we had no added difficulty in safely performing the procedure in them. Regarding postoperative recovery, patients were discharged 6 hours after the procedure without needing pain medication and were able to return to routine life activities within 24 hours after the procedure. There were no complaints of dyspareunia as identified by a standardized questionnaire administered on the follow-up visit on postoperative day 30. The transvaginal approach to intra-abdominal surgery seems a safe option for NOTES procedures as described in the literature and confirmed in our experience. Since specific endoscopic instruments are under development for advanced endoscopic surgery, NOTES transvaginal video-assisted laparoscopic cholecystectomy using regular laparoscopic instruments can be a safe alternative to perform surgery without visible abdominal scars and with the added benefit of a more comfortable postoperative recovery. Further studies with larger series and randomized studies comparing this technique to standard laparoscopic techniques must be carried out to reproduce and confirm this first experience of this approach to minimally invasive surgery.
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