Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series

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Hybrid natural orifice transluminal endoscopic cholecystectomy: Prospective human series Article in Surgical Endoscopy · January 2011 DOI: 10.1007/s00464-010-1121-z · Source: PubMed

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José F Noguera

Hospital Universitario Infanta Sofía

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José M Olea

Juan José Pujol

Hospital Universitari Son Espases

Hospital Son Llàtzer

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Surg Endosc (2011) 25:19–22 DOI 10.1007/s00464-010-1121-z

ORIGINAL ARTICLES

Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series Angel Cuadrado-Garcia • Jose F. Noguera • Jose M. Olea-Martinez • Rafael Morales • Carlos Dolz Luis Lozano • Jose-Carlos Vicens • Juan Jose´ Pujol



Received: 20 April 2009 / Accepted: 8 March 2010 / Published online: 10 June 2010 Ó Springer Science+Business Media, LLC 2010

Abstract Background Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. Currently, it is not possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids fusing minilaparoscopy and transluminal endoscopic surgery. This report presents a prospective clinical series of 25 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. Methods The study comprised a clinical series of 25 consecutive nonrandomized women who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two trocars for cholelithiasis: one 5-mm umbilical trocar and one 3-mm trocar in the upper left quadrant. The study had no control group. Results The scheduled surgical intervention was performed for all 25 women. No intraoperative complications occurred. One patient had mild hematuria that resolved in less than 12 h, but no other complications occurred during an average follow-up period of 140 days. Of the 25

Presented at the SAGES 2009 Annual Meeting, April 22–24, 2009, Phoenix, AZ. A. Cuadrado-Garcia (&)  J. F. Noguera  J. M. Olea-Martinez  R. Morales  C. Dolz  L. Lozano  J.-C. Vicens Surgery and Gastroenterology Department, Hospital Son Lla`tzer, Palma de Mallorca, Spain e-mail: [email protected] J. J. Pujol Surgery Department, Hospital Son Lla`tzer, Palma de Mallorca, Spain

women, 20 were discharged in 24 h, and 5 were discharged less than 12 h after the procedure. Conclusion Hybrid transvaginal cholecystectomy, combining NOTES and minilaparoscopy, is a good surgical model for minimally invasive surgery. It can be performed in surgical settings where laparoscopy is practiced regularly using the instruments normally used for endoscopy and laparoscopic surgery. Due to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future. Keywords Cholecystectomy  Minilaparoscopy  Natural orifice surgery  NOTES

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. The NOTES approach is a novel concept that involves a port of entry through a natural orifice to the peritoneal cavity for performance of diagnostic and therapeutic surgical interventions [1–3]. The NOTES approach may be superior to laparoscopic surgery in reducing postoperative abdominal wall pain, wound infection, hernia formation, and adhesions. Kalloo et al. [2] was the first to describe NOTES, which they used for animals in 2004. In early 2007, Zorro´n et al. [4], reporting from Brazil, described the first transvaginal cholecystectomy. In March 2007, Bessler et al. [5] reported a laparoscopically assisted transvaginal cholecystectomy. In April 2007, the procedure was performed by Marescaux et al. [6] using only an abdominal trocar that allowed creation of pneumoperitoneum and exertion of traction on the gallbladder with forceps.

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Currently, it is very difficult to perform these interventions without the help of abdominal wall entryways, so they are hybrids, a fusion of minilaparoscopy and transluminal endoscopic surgery or minilaparoscopically assisted natural orifice surgery (MANOS). This study aimed to evaluate whether hybrid NOTES/MANOS cholecystectomy at our hospital is feasible, reproducible, and safe.

Materials and methods This report presents a prospective clinical series of 25 consecutive women who underwent transvaginal hybrid cholecystectomy for 38 noncomplicated cholelithiasis cases nonrandomly chosen and without a control group. Preoperative evaluation

Fig. 1 Vaginal trocar

The study population included women with noncomplicated cholelithiasis diagnosed by ultrasound. Before surgery, all the patients underwent gynaecological examination. If Douglas’s pouch was obliterated, the patient was not considered a candidate for MANOS. All the women had antibiotic prophylaxis with metronidazole 500 mg and cefazolin 1,000 mg. No bowel cleaning was performed for any patient. After the study was approved by the Ethics and Clinical Research Committee of the Autonomous Community of the Balearic Islands, a specific informed consent was obtained from each patient.

MA, USA) using an additional 3-mm Ø abdominal right upper quadrant trocar (Karl Storz GmbH, Tuttlingen, Germany). The posterior vaginal cul-de-sac was visualized with the minilaparoscope. Under minilaparoscopic surveillance, the vaginal trocar, a 12-mm Ø XL trocar (Ethicon Endo-Surgery Inc., Cincinnati, OH, USA), was inserted into the middle of the cul-de-sac with gentle, steady pressure. The vaginal port was used to introduce a 10-mm Ø single-channel or 12-mm Ø double-channel gastroscope (Karl Storz GmbH) (Fig. 1). The MANOS procedure then was performed with 5- and 3-mm laparoscopic assistance instruments and endoscopic devices through the working channels. The function of the ports changed depending on the nature of the procedure.

Operating room assembly The operating room was assembled according to the standards for minimally invasive surgery. Two monitors were placed cephalad to the patient: one in the right shoulder and one in the left shoulder. This disposition of monitors was essential to allow proper visualization throughout the surgery, especially when the surgeon was operating from the vaginal port. Both monitors were movable and had an articulated arm, facilitating the view when the surgeon changed positions. All procedures were performed with the patient under general anesthesia and intubated endotracheally. The patient was placed in a semidorsolithotomy position. The vagina was cleaned with 10% povidone-iodine, and a pelvic examination was performed to confirm that no obstruction of the posterior cul-de-sac was present. A Foley catheter was placed. A pair of Breisky vaginal retractors was used to allow proper exposure of the posterior vaginal fornix. Pneumoperitoneum was induced with a Veress needle inserted into the umbilicus. The minilaparoscope was introduced through the 5-mm Ø umbilical port (VersaPort V2; Covidien AG, Mansfield,

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Cholecystectomy procedure Retraction of the gallbladder is obtained with a 3-mm Ø grasper introduced through the right upper quadrant miniport. For cholecystectomy, the hilum was dissected. When necessary, 3- or 5-mm forceps and scissors were inserted through the abdominal trocars. Calot’s triangle and supraCalot’s triangle were clearly identified. The 5-mm laparoscopic clip applier was introduced through the umbilical port. The cystic duct and the cystic artery were transected, and the gallbladder was dissected off the gallbladder bed with the hook or endoscopic cautery (Fig. 2). Specimen extraction was always performed vaginally within an endobag. The gallbladder was removed through the vaginal port using an endoscopic rat tooth forceps (Medi Globe GmbH, Achenmu¨le, Germany), and hemostasis was secured. When the specimen had been extracted, a 5-mm scope was introduced through an abdominal port, and the specimen was removed through the vaginal port

Surg Endosc (2011) 25:19–22

Fig. 2 Hook knife gallbladder bed dissection

under minilaparoscopic monitoring. The abdominal ports then were removed, and the incision in the posterior fornix for the vaginal port was closed with an absorbable suture [2, 7, 8].

Results In this series, 25 women with an average age of 39.7 years underwent surgery. All these women had an American Society of Anesthesiology (ASA) classification of 1 or 2 and a body mass index (BMI) less than 35 kg/m2. The scheduled surgical intervention was performed for all of the 25 patients who were indicated. In three cases, adhesyolisis was performed, and in one case, a hepatic atypical resection was performed due to a hepatic nodal hyperplasia in the gallbladder bed. Incidental benign ovarian cysts were found in two patients. Two other patients had mild acute/ subacute cholecystitis. The average surgical operative time was 89.5 min (range, 48–121 min). No intraoperative complications occurred. One patient had mild hematuria that resolved in less than 12 h, and another patient had a urinary tract infection. No other complications occurred during an average follow-up period of 180 days. No dispareunia, general complications, or surgical wound infections were detected. Of the 25 women, 20 were discharged in the following 24 h and 5 were discharged less than 12 h after the procedure. Follow-up visits up to 12 months after surgery showed no complications.

Discussion Hybrid transvaginal cholecystectomy, a combination of NOTES and minilaparoscopy, is a good surgical model for

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minimally invasive surgery. It can be performed in surgical settings where laparoscopy is practiced regularly using the instruments normally used for endoscopy and laparoscopic surgery. Currently, major surgical procedures are performed laparoscopically with increasingly smaller instruments. Small ports and instruments have many advantages over large ones such as lesser anesthesia requirements [9], less postoperative discomfort [10], decreased risk of adhesion formation [11], and reduced risk of incisional hernias [12, 13]. However, a major issue needs to be addressed with natural orifice surgery. This approach requires the creation of a perforation, still considered a major complication of endoscopy with significant morbidity and mortality. Although animal models have had a good evolution and have gained favor in experimental work [2, 14–17], safe and simple devices for gastrotomy and intestinal closure must be ensured before MANOS and NOTES are applied in clinical practice. Due to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES. Park et al. [16] successfully performed dissection with a needleknife, but other devices tested (e.g., endoscopic scissors and a suture cutter) were not strong enough to be useful during the dissection. After using different endoscopic methods (e.g., needleknife, hook knife), we prefer dissection with an electroprobe. The needleknife is more difficult to direct and more dangerous. Concurring with Park et al. and other groups, we think that endoscopic scissors have little use. Development of new platforms for endoscopy or retraction with magnets, as advocated by Scott et al. [18], could play an important role in the development NOTES. We agree with Horgan et al. [19] that the NOTES procedure must be safe and the operations easily replicated if the new technique is to become clinically relevant. Further data are needed to determine the safety and efficacy of NOTES. It is time to develop multicentric prospective clinical trials that compare laparoscopy and NOTES procedures.

Conclusion Transvaginal cholecystectomy is feasible and safe when performed by a multidisciplinary team working together. The NOTES technique is an emerging method that seems to be less invasive, better tolerated, and more respectful of aesthetics than laparoscopic surgery. It probably will open the way for very important medical and technological innovations over the coming years. Disclosures Angel Cuadrado-Garcia, Jose F. Noguera, Jose M. Olea-Martinez, Rafael Morales, Carlos Dolz, Luis Lozano, Jose-

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22 Carlos Vicens, and Juan Jose´ Pujol have no conflicts of interest or financial ties to disclose.

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Surg Endosc (2011) 25:19–22 10. Risquez F, Pennehoaut, McCorvey R et al (1997) Diagnostic and operative microlaparoscopy: a preliminary multicenter report. Hum Reprod 12:1645–1648 11. Almeida OD, Val-Gallas JM, Rizk B (1998) Appendectomy under local anesthesia following conscious pain mapping with microlaparoscopy. Hum Reprod 13:588–590 12. Montz FJ, Holschneider CH, Munro MG (1994) Incisional hernia following laparoscopy: a survey of the American Association of Gynecologic Laparoscopists. Obstet Gynecol 84:881–884 13. Rabinnerson D, Avrech O, Neri A et al (1997) Incisional hernias after laparoscopy. Obstet Gynecol Surv 52:701–703 14. Pai RD, Fong DG, Bundga ME, Odze RD, Rattner DW, Thompson CC (2006) Transcolonic endoscopic cholecystectomy: a NOTES survival study in a porcine model. Gastrointest Endosc 64:428–434 15. Wagh MS, Merrifield BF, Thompson CC (2005) Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model. Clin Gastroenterol Hepatol 3:892– 896 16. Park PO, Bergstrom M, Ikeda K, Fritscher-Ravens A, Swain P (2005) Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastomosis. Gastrointest Endosc 61:601–606 17. Jagannath SB, Kantsevoy SV, Vaughn CA et al (2005) Peroral transgastric endoscopic ligation of fallopian tubes with longterm survival in a porcine model. Gastrointest Endosc 61:449–453 18. Scott DJ, Tang SJ, Fernandez R, Bergs R, Goova MT, Zeltser I, Kehdy FJ, Cadeddu JA (2007) Completely transvaginal NOTES cholecystectomy using magnetically anchored instruments. Surg Endosc 21:2308–2316. Epub 18 August 2007 19. Horgan S, Cullen JP, Talamini MA, et al. (2009) Natural orifice surgery: initial clinical experience. Surg Endosc 23:1512–1518. Epub 3 April 2009

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