Evaluation for transvaginal and transgastric NOTES cholecystectomy in human and animal natural orifice translumenal endoscopic surgery

Background/purpose  Natural orifice translumenal endoscopic surgery (NOTES) is a novel concept using an endoscope via a translumenal access for abdominal surgery. This study was designed to evaluate the feasibility and technical aspects of NOTES cholecystectomy from our experience on humans and animals. Methods  NOTES cholecystectomies were performed in 12 animal experiments, including 8 pigs (6 by transgastric and 2 by transvaginal accesses) and 4 dogs (4 transvaginal accesses), and a human female cadaver. Results  The entire gallbladder could be removed under direct vision in all experiments. The average time was 60 min by transgastric and 40 min by transvaginal in animals. It was 87 min for human transvaginal cholecystectomy. In all animal and human procedures, there was no major complication concerning the operation. Discussion  The transvaginal route may be the easiest route for abdominal NOTES. Percutaneous endoscopic gastrostomy (PEG) allowed the safe performance of a controlled gastric perforation and shortened the time. The hybrid method allowed performance of a safe procedure and shortened the time. Conclusions  Transvaginal and transgastric NOTES cholecystectomy is technically feasible and safe in both humans and animals. New instrumentation needs to be developed to perform a pure NOTES cholecystectomy without transabdominal assistance.     

Challenges and lessons learned from NOTES cholecystectomy initial experience: a stepwise approach from the laboratory to clinical application

Background/Purpose  The initial idea behind natural orifice transluminal endoscopic surgery (NOTES) was that of an incisionless surgery. NOTES cholecystectomy is a good model of human ingenuity and technological advance. NOTES cholecystectomy in a human being was performed at our institution after extensive laboratory work in live pig models. In this process we gained helpful information related to NOTES cholecystectomy. Methods  More than 250 cholecystectomies in pigs have been performed. From May 2007 to November 2008 a total of 10 and 6 transvaginal and transgastric human cholecystectomies, respectively, have been performed. Results  The procedure was successful in all patients, with a mean operative time of 120 min. There were no intraoperative or postoperative complications. Patients recovered promptly after surgery and had minor postoperative pain. They were discharged on the second postoperative day. Conclusions  The advantages of laparoscopy appeared to be enhanced by this approach: patients had minor postoperative pain and minimal scarring. This stepwise experience in the cholecystectomy procedure is an important first step in the development of methods and devices to enable the evaluation of potential incisionless NOTES surgery. Additional research and comparison studies are needed for further improvement in order to provide NOTES procedures to a wider range of patients.     

Human NOTES Cholecystectomy: Transgastric Hybrid Technique

Background  Natural orifice translumenal endoscopic surgery (NOTES) is an emerging field in minimally invasive surgery that is driving the development of new technology and techniques. There are several proposed benefits to the NOTES approach, including potentially decreased abdominal pain, wound infections, and hernia formation Ko and Kalloo (Chin J Dig Dis 7:67–70, 2006); Wagh et al. (Clin Gastroenterol Hepatol 3(9):892–896, 2005); ASGE/SAGES Working Group on Natural Orifice Transluminal Endoscopic Surgery (Gastrointest Endosc 63(2):199–203, 2006); and Pearl and Ponsky (J GI Surg 12:1293–1300, 2008). Cholecystectomy has been one of the most commonly performed NOTES procedures to date, with the majority being performed through the transvaginal approach Marescaux et al. (Arch Surg 142:823–826, 2007); Zorron et al. (Surg Endosc 22:542–547, 2008); and Ramos et al. (Endoscopy 40:572–575, 2008). Transgastric approaches for cholecystectomy have been shown to be technically feasible in animal models and in several unpublished human patients Sumiyama et al. (Gastrointest Endosc 65(7):1028–1034, 2007). This video demonstrates the technique by which we perform transgastric NOTES hybrid cholecystectomy in human patients. Method  Patients with symptomatic gallstone disease are enrolled under an IRB approved protocol. A diagnostic EGD is performed to confirm normal anatomy. Peritoneal access is gained using a needle-knife cautery and balloon dilation under laparoscopic visualization. Dissection of the critical view of safety is performed endoscopically. The cystic duct and artery are clipped laparoscopically and the gallbladder is dissected off of the liver. The gastrotomy is closed intralumenally and over-sewed laparoscopically. The gallbladder is extracted out the mouth. Results  This technique was used to successfully perform four NOTES hybrid transgastric cholecystectomies without operative complications. Conclusions  NOTES hybrid transgastric cholecystectomy can be performed safely in human patients. This procedure is still technically challenging given the current instrumentation that is available. In order to perform a pure NOTES transgastric cholecystectomy, a safe blind access method, improved retraction, endoscopic hemostatic clips, and reliable closure methods need to be developed. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users. Presented at SSAT/DDW, May 2008, San Diego, CA.     

NOTES: cadaveric rendezvous hybrid small bowel resection

Background  Natural orifice translumenal endoscopic surgery (NOTES) is an emerging field in minimally invasive surgery that is driving the development of new technology and techniques [1–4]. Before NOTES gains widespread popularity, it must be proven to be a safe and efficacious technique [5]. There are several proposed benefits to the NOTES approach, including potentially decreased abdominal pain, wound infections, and hernia formation. Methods  Currently, most investigational NOTES procedures are performed using a single transgastric, transcolonic, or transvaginal access point to the abdomen. In order to provide greater range of motion and freedom of movement, a rendezvous procedure using simultaneous transgastric and transcolonic approaches was used to perform a small bowel resection. This video demonstrates a successful NOTES hybrid small bowel resection with the use of two laparoscopic ports in a cadaveric model. A powered stapling device attached to a flexible shaft is introduced transcolonically and facilitates division and re-anastamosis of the small bowel. A dual-channel operating endoscope introduced transgastrically allows for precise dissection and creation of enterotomies necessary for the small bowel resection. Conclusions  While technically challenging, NOTES hybrid small bowel resection can be accomplished with specially designed instrumentation utilizing the rendezvous technique. There are several technical limitations preventing this procedure from being completed in a pure NOTES fashion. A safe method of creating blind enterotomies will be needed to eliminate laparoscopic visualization of the enterotomy sites. Adequate endoscopic exposure and retraction of tissue is still difficult and currently requires percutaneous adjuncts. New closure devices will be needed for safe and reliable NOTES enterotomy closure. With the development of such instruments, this, as well as other NOTES procedures, will become more technically feasible. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.     

Per-oral dual scope NOTES cholecystectomy in porcine model (with video)

Background  

Several working groups have already demonstrated the feasibility of transgastric surgery procedures using flexible endoscopes. However, technical limitations in natural orifice translumenal endoscopic surgery (NOTES) (e.g., exposure, retraction, insufflations, and triangulation) currently still require the use of at least one external instrument [1–3]. Therefore, “pure NOTES” transgastric cholecystectomy has not yet been described. The authors successfully performed “pure NOTES” transgastric cholecystectomy using a transoral dual-scope technique (similar to the approach the authors previously reported for gastric closure [4]) that allows completion of the procedure by pure NOTES without an external instrument.     

The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report

Background

The EURO-NOTES Clinical Registry (ECR) was established as a European database to allow the monitoring and safe introduction of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The aim of this study was to analyze different techniques applied and relative results during the first 2 years of the ECR.

Methods

The ECR was designed as a voluntary database with online access. All members of the European Society for Gastrointestinal Endoscopy and the European Association for Endoscopic Surgery were requested to participate in the registry. Demographic and therapy data as well as data on the postoperative course are recorded in the ECR in an anonymous way.

Results

A total of 533 patients who underwent NOTES procedures were included in the study. Four different hybrid techniques for 435 cholecystectomies were described, registering postoperative complications in 2.8 % of patients, addition of a single trocar in 5.3 %, and conversions to laparoscopy in 0.5 %. Both flexible endoscopic and rigid laparoscopic cholecystectomy techniques proved to be safe and effective with minor differences. There was a shorter operative time in the rigid laparoscopic group. Thirty-three appendectomies were reported by transgastric and transvaginal techniques, with transvaginal techniques scoring shorter operative time and hospital stay, but with a frequent need to add more trocars. Overall complications occurred in 14.7 % of patients but they did not differ significantly among the different techniques. One transvaginal and 31 transanal sigmoidectomies were included for prolapse and diverticulitis, with four postoperative complications (12.5 %), but none needing further treatment. Twenty peroral esophageal myotomies were included with three postoperative complications (15.0 %), but none needing further treatment.

Conclusions

Five years since the introduction of NOTES into clinical practice, hybrid techniques have gained considerable clinical application. Several NOTES hybrid cholecystectomy and appendectomy techniques are practicable and safe alternatives to laparoscopic procedures. Also, sigmoidectomies and peroral esophageal myotomies were described, proving feasibility and safety. Nevertheless, the real benefit of NOTES for patients still needs to be assessed.     

Totally transvaginal resection of the descending colon in an experimental model

Background  

Natural orifice translumenal endoscopic surgery (NOTES), although in its embryonic phase, is currently experiencing important developments. The technique has been successfully applied for cholecystectomies and appendectomies. However, several doubts exist as to the technical limitations and feasibility of NOTES in other clinical settings.     

Natural orifice surgery: initial clinical experience

Background  Natural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience. Methods  Under an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance. Results  Nine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred. Conclusion  The limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.     

Is the transvaginal route appropriate for intra-abdominal NOTES procedures? Experience and follow-up of 222 cases

Background

Since 2007, natural orifice transluminal endoscopic surgery (NOTES) has been applied in humans. We performed this prospective study to evaluate the transvaginal route in terms of risks, complication rate, and long-term side effects such as dyspareunia.

Methods

From June 2007 to September 2011, we performed 222 transvaginal hybrid NOTES procedures: 220 transvaginal cholecystectomies (TVC) and 2 transvaginal appendectomies (TVA). All patients were asked to present to our associated gynecologists within 1 week for an examination. After at least 3 months, the patients were interviewed using a standard questionnaire.

Results

All operations could be successfully performed in this technique except two cases, which were converted to conventional laparoscopic cholecystectomy. The only intraoperative complication was the puncture of the urine bladder. We observed two postoperative complications: one biliary fistula 3 days after TVC, and one abscess in the Douglas pouch 3 weeks after TVC. The gynecological examinations revealed no abnormalities. The interview (median postoperative time, 6 months) with a follow-up rate of 93 % revealed no pain in the pelvis, dyspareunia, or sexual dysfunction after TVC.

Conclusions

The transvaginal route is appropriate for NOTES procedures; there is only a minor and acceptable rate of intra- and postoperative morbidity.     

Natural Orifice Translumenal Endoscopic Surgery: A Critical Review

Natural orifice translumenal endoscopic surgery (NOTES) involves the intentional puncture of one of the viscera (e.g., stomach, rectum, vagina, urinary bladder) with an endoscope to access the abdominal cavity and perform an intraabdominal operation. Early laboratory work focused on feasibility studies, including such accomplishments as pure transgastric splenectomy and gastrojejunostomy. Contemporary laboratory work is investigating the infectious and immunologic implications of NOTES and honing the tools and techniques required for complex abdominal operations. Today NOTES has entered the clinical arena in a few cases: the first clinical series of transgastric peritoneoscopy has recently been published; multiple groups are accumulating patients in studies of NOTES cholecystectomy, either via the transgastric or transvaginal route; and a series of transgastric appendectomies has been well publicized, yet it remains unpublished. Although clinical NOTES is gaining momentum, the field should remain in check while rigorous laboratory work is performed and cogent clinical trials are undertaken. The zeal for NOTES should not take precedence over the welfare of the patient.     

Pure natural orifice transluminal endoscopic surgery (NOTES) cholecystectomy

Enthusiasm for natural orifice transluminal endoscopic surgery (NOTES) has been partly tempered by the reality that most NOTES procedures to date have been laparoscopically assisted. After safely performing transvaginal cholecystectomy in an IACUC-approved porcine model, the authors embarked on an institution review board (IRB)-approved protocol for ultimate performance of pure NOTES cholecystectomy in humans. They describe their experience performing a true NOTES transvaginal cholecystectomy after safely accomplishing three laparoscopically assisted or hybrid procedures in humans. One of the patients was a 35-year-old woman presenting with symptoms of biliary colic. Ultrasound confirmed gallstones, and her liver enzymes were normal. Pneumoperitoneum to 15 mmHg was obtained via a transvaginal trocar placed through a colpotomy made under direct vision. A double-channel endoscope then was advanced into the abdomen. To overcome the retracting limitations of currently available endoscopes, the authors used an extra-long 5-mm articulating retractor placed into the abdomen via a separate colpotomy made under direct vision using the flexible endoscope in a retroflexed position. Endoscopically placed clips were used for control of both the cystic duct and the artery. These techniques obviated the need for any transabdominally placed instruments or needles. This patient was the first to undergo a completely NOTES cholecystectomy at the authors’ institution, and to their knowledge, in the United States. She was discharged on the day of surgery and at this writing has not experienced any complication after 1 month of follow-up evaluation. Performance of NOTES transvaginal cholecystectomy without aid of laparoscopic or needleoscopic instruments is feasible and safe for humans. Additional experience with this technique are required before studies comparing it with standard laparoscopy and hybrid techniques are appropriate.     

Natural orifice translumenal endoscopic surgery (NOTES): creation of a gastric valve for safe and effective transgastric surgery in humans

Introduction  

NOTES has become a clinical reality. There remain, however, many challenges that need to be addressed in order to refine the technique. One of the most feared potential complications of transgastric surgery is a leak from the port of entry into the peritoneum. When withdrawing the endoscope into the gastric lumen it is difficult to make a secure closure due to the loss of pneumogastrium. We present a novel and safe technique for creating a gastrotomy developed in our animal laboratory and applied in all of our human NOTES cholecystectomies.     

Early experience in human hybrid transgastric and transvaginal endoscopic cholecystectomy

Background  

Abdominal procedures have been performed for a long time through the anterior abdominal wall. Since the first reports in the 1980s, laparoscopy has become the standard for cholecystectomy, with many advantages over open procedures. Now a natural-orifice approach to the peritoneal cavity may further reduce the invasiveness of surgery by either diminishing or avoiding abdominal incisions. Several orifice routes to the abdominal cavity have been described: transgastric, transvaginal, transvesical, and transcolonic. Although most experiences with the porcine model showed the possibility of these approaches, few surgeons reported experiences with humans. The authors present their complete early experience with transgastric (TG) and transvaginal (TV) cholecystectomies in human beings.     

Laparoscopy and natural orifice surgery: first entry safety surveillance step

Background and Objective:

We are sharing information regarding the surveillance of the first entrance port in laparoscopic and natural orifice transvaginal endoscopy surgeries. However, we are not analyzing techniques or other surgical findings.

Method:

In this study, 160 women with previous abdominal pelvic surgeries underwent laparoscopic surgery, 145 patients underwent transvaginal Minilaparoscopy Assisted Natural Orifice Surgery (hybrid), and 3 patients underwent pure natural orifice transvaginal endoscopic surgery (pure). For those patients who had laparoscopy and hybrid procedures, the surveillance was from a laparoscope or gastroscope placed in a secondary port. Surveillance in pure cases was done using a gastroscopic retro view to see the pouch of Douglas.

Results:

The laparoscopic procedures were gynecological procedures. The hybrid procedures included gynecological procedures as well as appendectomies and cholecystectomies; the pure procedures were cholecystectomies. There were a few minor vascular and bowel injuries in the laparoscopy group. There were no injuries in the transvaginal hybrid or pure procedures groups.

Conclusion:

The surveillance of the first entrance port can be an effective precautionary step. The cumulative experience suggests that using such surveillance in cases involving patients with prior surgery may assist in recognizing complications that might otherwise be missed.     

Reducing the unexpectedly high rate of injuries caused by NOTES gastrotomy creation

Background  

Despite the wide range of natural orifice transluminal endoscopic surgery (NOTES) procedures reported to date using a transgastric endoscopic approach, complications associated with gastrotomy creation have not been described. This study was conducted to identify the incidence and types of complications related to gastrotomy creation with the needle knife puncture and balloon dilatation technique for NOTES access to the peritoneal cavity.     

Female Sexual Function After Pure Transvaginal Appendectomy: A Cohort Study

Background  

The impact of transvaginal natural orifice transluminal endoscopic surgery (NOTES) on female sexual function is unknown. We therefore performed a prospective cohort study of women undergoing pure transvaginal appendectomies (TVA) versus traditional laparoscopic appendectomies (LA). Using a validated, 19-point, female sexual function index questionnaire (FSFI) assessing six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain with intercourse), pre- and postoperative sexual function was compared.     

Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series

Introduction  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. It is not yet possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids, a fusion of minilaparoscopy and transluminal endoscopic surgery. In this paper we present a prospective clinical series of 15 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. Methods  This was a prospective clinical series of 15 consecutive female patients, nonrandomly chosen and without a control group, who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two entryways for cholelithiasis. One was umbilical and measured 5 mm in diameter, and the other was in the right upper quadrant and measured 3 mm in diameter. Results  The scheduled surgical intervention was performed on the 15 patients in whom it had been indicated. There were no intraoperative complications. One patient had mild hematuria that resolved in less than 12 h; there were no other complications after average follow-up of 124 days. Nine patients were discharged in 24 h, and two were discharged less than 12 h after the procedure. Discussion  Hybrid transvaginal cholecystectomy is a good surgical model for minimally invasive surgery, a combination of NOTES and minilaparoscopy. It can be performed in surgical settings where laparoscopy is practised regularly, using the instruments normally used for endoscopy and laparoscopic surgery. Owing to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.     

Development of a feasible transrectal natural orifice transluminal endoscopic surgery (NOTES?) approach in a cadaveric appendectomy model: anterior is better

Background  

The transrectal natural orifice transluminal endoscopic surgery (NOTES) approach is a potentially promising alternative to transgastric or transvaginal approaches for intraperitoneal procedures. However, whether the optimal transrectal approach for intraperitoneal surgery is anterior or posterior remains unknown. To evaluate this, a prospective comparison of anterior and posterior transrectal NOTES approaches in a cadaveric appendectomy model was performed.     

Pure natural orifice transluminal endoscopic surgery (NOTES) nephrectomy using standard laparoscopic instruments in the porcine model

PURPOSE: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an emerging technology that uses endoscopic instruments passed into the peritoneal cavity through hollow viscera to perform surgical procedures without the use of abdominal incisions. There are, however, limitations regarding the equipment available to simulate traditional surgery. The aim of this study was to determine the feasibility of a pure NOTES nephrectomy by using standard laparoscopic instruments through a modified transvaginal trocar. MATERIALS AND METHODS: One 40-kg female swine underwent transgastric peritoneoscopy. Transgastric endoscopic visualization guided the introduction of a second transvaginal endoscope through a novel laparoscopic trocar/endoscopic overtube device. The retroflexed transgastric endoscope provided triangulated visualization as standard endoscopic instruments provided retraction, which allowed dissection of the kidney with standard laparoscopic instruments through our modified transvaginal trocar device. Each renal hilum, artery, vein, and ureter was dissected and divided with a transvaginal laparoscopic stapler. RESULTS: Transgastric and transvaginal NOTES accesses were easily achieved, and bilateral nephrectomies were performed. Completion of peritoneoscopy revealed complete hemostasis and identification of ligated ureters and hilar vessels. Total operative time was 40 and 20 minutes for the right and left kidney, respectively. One kidney was captured with a laparoscopic retrieval sac and removed intact through the vaginal defect. CONCLUSIONS: Pure NOTES nephrectomies are technically feasible in the porcine model by using standard laparoscopic instruments. Survival studies are necessary to determine the long-term complications and physiologic implications of NOTES nephrectomy. The development of innovative NOTES access trocars may allow for an increased armamentarium of NOTES instruments.     

Peroral transgastric endoscopic procedures in pigs: feasibility, survival, questionings, and pitfalls

Background  Multiple studies have demonstrated the feasibility of peroral transgastric endoscopic procedures in porcine models. We present our experience with these procedures in a porcine survival model and expose the technical difficulties and worries about their application in humans. Methods  We performed the following transgastric procedures in nine small pigs (20–30 kg) under general anesthesia using a double-channel therapeutic endoscope: peritoneoscopy (nine pigs), cholecystectomy (six pigs), gastrojejunal anastomosis (two pigs), and fallopian tube excision (one pig). Postsurgical complications and survival of the pigs were recorded during a 3-week follow-up. Results  In six pigs, the gallbladder was successfully resected. The time of the procedure ranged from 2.5 to 3.5 hours. In one case, severe bleeding occurred from the cystic artery during dissection and was successfully managed by placement of endoscopic clips. Five pigs survived for 3 weeks after cholecystectomy. In one pig, severe peritonitis developed because of gastric contents leakage due to failure of gastric closure and the animal was euthanized 3 days after the procedure. Endoscopic transgastric gastrojejunostomy was successfully performed in two pigs without major complications. The time required for the procedure averaged about 50 min. Fallopian tube excision was also successful in one pig without any complications. The entire procedure was performed within 60 min. Conclusions  This study reports the feasibility of natural orifice transluminal endoscopic surgery (NOTES) procedures in a porcine survival model and impresses the efficacy, the safety, the complications, and some technical difficulties of transgastric NOTES procedures, which merit further evaluation in future studies.