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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
8 authors, including: Angel Cuadrado-Garcia
José F Noguera
Hospital Universitario Infanta Sofía
Consorcio Hospital General Universitario de …
30 PUBLICATIONS 362 CITATIONS
70 PUBLICATIONS 510 CITATIONS
José M Olea
Juan José Pujol
Hospital Universitari Son Espases
Hospital Son Llàtzer
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3 PUBLICATIONS 41 CITATIONS
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Surg Endosc (2011) 25:19–22 DOI 10.1007/s00464-010-1121-z
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.  was the first to describe NOTES, which they used for animals in 2004. In early 2007, Zorro´n et al. , reporting from Brazil, described the first transvaginal cholecystectomy. In March 2007, Bessler et al.  reported a laparoscopically assisted transvaginal cholecystectomy. In April 2007, the procedure was performed by Marescaux et al.  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,
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
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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
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 , less postoperative discomfort , decreased risk of adhesion formation , 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.  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. , could play an important role in the development NOTES. We agree with Horgan et al.  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-
22 Carlos Vicens, and Juan Jose´ Pujol have no conflicts of interest or financial ties to disclose.
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