In the ongoing effort to limit the physical impact of surgery on the human body, researchers are taking minimally invasive gallbladder removal to the next logical step. Instead of removing the organ through the abdominal wall, surgeons in the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) are performing cholecystectomy through the mouth or the vagina.
Earlier this year, transoral and transvaginal cholecystectomies were performed by Dr. Santiago Horgan and Dr. John Romanelli, respectively, as part of a new clinical trial designed to provide the first multicenter, prospective, randomized, controlled, noninferiority evaluation of these two natural orifice methods with the laparoscopic approach.
Cholecystectomy, usually for benign gallstone disease, is one of the most common surgical procedures; roughly 750,000 such operations are performed annually in the United States. The goal of natural orifice surgery is to eliminate the need to pierce the abdominal wall during gallbladder removal, thereby lessening the risk of complications and additional pain.
About the Trial
The trial (NCT01171027) was announced in July 2010 and began this year. It has an estimated enrollment of approximately 150 patients. The primary outcome measure is to assess the safety and efficacy of transgastric and transvaginal cholecystectomy, compared with conventional laparoscopic cholecystectomy up to 4 weeks after surgery.
The secondary outcome is to assess pain associated with the oral and the vaginal techniques, as compared with conventional laparoscopic cholecystectomy up to 4 weeks post surgery. Cosmesis associated with transgastric and transvaginal cholecystectomy will also be compared with conventional laparoscopic cholecystectomy as well as costs.
The ultimate goal is to develop the technology further so that the transoral and transgastric approaches would not require any incisions in the abdominal wall. Patient recruitment information is available at the NOSCAR website.
Dr. David W. Rattner
When asked to comment on the trial, Dr. David W. Rattner, chief of the division of gastrointestinal and general surgery, Massachusetts General Hospital, Boston, stated: "It is important to note that while over 5,000 transvaginal cholecystectomies have been performed worldwide, this is the first prospective, randomized study to compare NOTES [natural orifice translumenal endoscopic surgery] approaches to a standard therapy for benign gallstone disease. Principal investigators Dr. Michael Kochman at the University of Pennsylvania, Philadelphia, and Dr. Steven L. Schwaitzberg at Harvard University, Cambridge, initiated all of the hard work to make this important comparative trial happen."
Surgical Approaches
The transgastric cholecystectomy is being performed through the use of an orally introduced flexible endoscope to provide working channels and visualization, followed by a gastrotomy made through the stomach wall, allowing the endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out of the mouth.
The first such operation in the study was performed by Dr. Horgan of the University of California, San Diego. The transvaginal approach is being performed using a posterior colpotomy and a flexible endoscope instead of a conventional laparoscope. The gallbladder is removed from the vaginal incision. The first such operation in the study was performed by Dr. Romanelli of the Baystate Medical Center in Springfield, Mass.
Both approaches are being compared with a version of traditional laparoscopic cholecystectomy in which a laparoscope is introduced through a 1-cm incision in or around the umbilicus, usually with three additional 0.5- to 1.0-cm incisions employed for surgical instrumentation. The gallbladder is typically removed through the umbilical port. According to the clinical trial summary, "the most devastating complication is injury to the major bile ducts." The reported incidence is 0.2% to less than 0.01% and is best avoided by careful visualization of the ductal structures.
For this trial, both the transgastric and the transvaginal approaches have included the use of a 5-mm puncture in the umbilicus so that a small laparoscope can be used to monitor the procedure for optimum safety and visualization.
Other sites currently participating in the trial include Yale University, New Haven, Conn.; Ohio State University, Columbus; Northwestern University, Chicago; and the Oregon Clinic, Portland.
Patient Inclusion/Exclusion
To be accepted for the trial, patients must be between the ages of 18 and 75 years and present with a diagnosis of benign gallstone disease requiring elective cholecystectomy. Men will be randomized to either transgastric NOTES or laparoscopic surgery, and women will be randomized to all three options.
Patients cannot be obese (BMI greater than 35 kg/m2) or have comorbidities greater than ASA P1 or P2. Patients must not have chronic renal failure, chronic liver disease, or presumed gallbladder malignancy, nor can they be on anticoagulation drugs other than once-daily aspirin.