First NOTES transoral and transvaginal gallbladder removals performed as part of United States multicentre human trial

Oak Brook 07 July 2010The Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), a joint effort of the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), has completed the first transoral and transvaginal cholecystectomies (gallbladder removal) using Natural Orifice Translumenal Endoscopic Surgery (NOTES) in a multicentre human trial in the United States. Santiago Horgan, MD, at the University of California, San Diego (UCSD) School of Medicine, removed the gallbladder of a patient through the mouth and John Romanelli, MD, Baystate Medical Center in Springfield, Massacusetts, removed the gallbladder of a patient through the vagina as part of the NOSCAR human trials. NOTES is performed by using the patient's natural openings for surgery. These human trials are the first in the world comparing oral and transvaginal NOTES to traditional laparoscopy.

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"NOSCAR congratulates Drs. Horgan and Romanelli for these major accomplishments. These are the first NOTES transoral and transvaginal cholecystectomies in a United States multicentre human trial and are a big step forward in the evolution of this revolutionary procedure", stated Michael L. Kochman, MD, NOSCAR Research Subcommittee co-chair.

Cholecystectomy or gallbladder removal is one of the most common surgeries in the United States; approximately 750.000 are performed annually. This study uses the mouth or vagina as routes to the gallbladder. Rather than making up to five incisions in the abdominal wall, tools are passed down the mouth and through a hole created in the stomach (transgastric) or through the vagina (transvaginal). Dr. Horgan opted to make a tiny incision in the stomach, requiring no stitches, to pass a camera and to inflate the abdomen for optimal safety and visibility. The actual gallbladder removal was performed entirely through the mouth. Dr. Romanelli also made a small abdominal incision for similar reasons as Dr. Horgan, to ensure the safety of the procedure. He extracted the gallbladder through the vagina.

"What is unique about this trial is that we will not only evaluate the safety and efficacy of NOTES compared to laparoscopy but will also assess and compare pain levels, cosmetic outcomes, operative costs and logistical outcomes", stated Dr. Horgan, who has performed more than 70 NOTES surgeries. Dr. Horgan, director of UCSD's Center for the Future of Surgery, said that traditional laparoscopy is a highly effective technique but that there is always room for improvement in reducing post-operative infection, hernia, scarring and pain. "We hypothesize that NOTES procedures may reduce pain and infection by eliminating abdominal wall incisions altogether", stated Dr. Horgan. "Post-operatively, many patients experience pain while walking or coughing due to contraction of the abdominal muscles. This discomfort is absent following the natural orifice approach."

"We are excited to announce the completion of the first transoral and transvaginal cholecystectomies in the NOTES human trials. UCSD and Baystate Medical Center are at the forefront of NOTES research and their participation in these human trials is providing invaluable knowledge that is taking NOTES to the next level", stated Steven D. Schwaitzberg, MD, NOSCAR Research Subcommittee co-chair.

The human trials were announced last summer and began earlier this year. The prospective multicentre trial compares NOTES cholecystectomy versus conventional laparoscopic cholecystectomy. NOSCAR has granted funds to selected institutions to conduct these trials. Institutions participating in the trial have demonstrated a strong commitment to developing the basic science that forms the foundation of NOTES and have already performed human NOTES cases under an Institutional Review Board protocol; approximately 200 patients will be enrolled in the clinical trial.

Until now, NOSCAR research efforts have focused on basic research. Continuing research commitments from industry partners Ethicon Endo-Surgery, Olympus America Inc., Stryker Medical and KARL STORZ Endoscopy-America are providing funds to support the human study in this emerging transdisciplinary therapy. ACI, a Clinical Research Organization based in Pennsylvania, has been retained to provide data collection and report preparation services for the study.

Natural Orifice Translumenal Endoscopic Surgery (NOTES) might represent the next major advancement in minimally invasive therapy. To address this emerging technology, a working group consisting of expert laparoscopic surgeons from SAGES and a group of expert interventional endoscopists representing ASGE have joined together as the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR).

The growing capabilities of therapeutic flexible endoscopy have ushered in a new era in treatment of gastro-intestinal conditions. Refinements in laparoscopic surgery have progressed to the point that complex surgical procedures, such as gastric bypass, can now be performed in a minimally invasive fashion. These trends have set the stage for the development of even less invasive methods to treat conditions in both the gut lumen and in the peritoneal cavity. It seems feasible that major intraperitoneal surgery may one day be performed without skin incisions. The natural orifices may provide the entry point for surgical interventions in the peritoneal cavity thereby avoiding abdominal wall incisions.

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) was founded in 1981 to foster, promote, support and encourage academic, clinical and research achievement in gastro-intestinal endoscopic surgery. SAGES members are general and colorectal surgeons who perform endoscopy and laparoscopy as part of their practice as well as surgical residents, fellows, and other allied health personnel. The Society has grown from fewer than 50 original members to more than 5500 from every state and over 80 countries.

Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence in gastro-intestinal endoscopy. ASGE, with more than 11.000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education.


Source: American Society for Gastrointestinal Endoscopy

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