Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
NCT ID: NCT01171027
Last Updated: 2011-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2010-07-31
2012-09-30
Brief Summary
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Detailed Description
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To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Secondary To assess cosmesis associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To assess objective operative cost and logistical comparisons between transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To identify unforeseen barriers to transgastric or transvaginal surgery adoption.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NOTES(R) Cholecystectomy
Natural Orifice Translumenal Endoscopic Surgery techniques
NOTES Cholecystectomy
The transvaginal NOTES approach is accomplished by performing a posterior colpotomy. Instead of a conventional laparoscope, a flexible endoscope is used in order to provide working channels and visualization. The gallbladder is removed through the vaginal incision. The transgastric cholecystectomy requires the flexible endoscope to be placed orally. A gastrotomy is made through the stomach wall allowing the flexible endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out the mouth. The goal of NOTES is to develop further so either of these approaches will not require any incisions in the abdominal wall.
Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
NOTES Cholecystectomy
The transvaginal NOTES approach is accomplished by performing a posterior colpotomy. Instead of a conventional laparoscope, a flexible endoscope is used in order to provide working channels and visualization. The gallbladder is removed through the vaginal incision. The transgastric cholecystectomy requires the flexible endoscope to be placed orally. A gastrotomy is made through the stomach wall allowing the flexible endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out the mouth. The goal of NOTES is to develop further so either of these approaches will not require any incisions in the abdominal wall.
Laparoscopic Cholecystectomy
This technique utilizes the introduction of a laparoscope through a 1 cm incision in the fascia in or around umbilicus. Usually three additional 0.5- 1.0 cm incisions are employed for surgical instrumentation. Once separated from its attachments, the gallbladder is usually removed through the umbilical port. Sutures are used to close the larger port sites. The most devastating complication is injury to the major bile ducts which is avoided to the extent possible (incidence .2 to less than .01%)5 by careful visualization of the ductal structures.
Interventions
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NOTES Cholecystectomy
The transvaginal NOTES approach is accomplished by performing a posterior colpotomy. Instead of a conventional laparoscope, a flexible endoscope is used in order to provide working channels and visualization. The gallbladder is removed through the vaginal incision. The transgastric cholecystectomy requires the flexible endoscope to be placed orally. A gastrotomy is made through the stomach wall allowing the flexible endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out the mouth. The goal of NOTES is to develop further so either of these approaches will not require any incisions in the abdominal wall.
Laparoscopic Cholecystectomy
This technique utilizes the introduction of a laparoscope through a 1 cm incision in the fascia in or around umbilicus. Usually three additional 0.5- 1.0 cm incisions are employed for surgical instrumentation. Once separated from its attachments, the gallbladder is usually removed through the umbilical port. Sutures are used to close the larger port sites. The most devastating complication is injury to the major bile ducts which is avoided to the extent possible (incidence .2 to less than .01%)5 by careful visualization of the ductal structures.
Eligibility Criteria
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Inclusion Criteria
* Male subjects must be willing to have the cholecystectomy by either the laparoscopic or transgastric NOTES approach.
* Female subjects must be willing to have the cholecystectomy by either the laparoscopic or either the NOTES approaches (transgastric and/or transvaginal) being performed at the site.
* Patients offered participation in this study must provide written, informed consent and meet the following criteria prior to randomization.
* Diagnosis of benign gallstone disease which requires cholecystectomy.
* ASA Class 1 or 2.
* Willingness to have laparoscopic cholecystectomy performed and have research data collected for control group.
* Willingness to have abdomen photographed (for cosmesis assessment).
* For sites performing transgastric NOTES approach
* Willingness to have cholecystectomy performed via NOTES transgastric approach.
* Willingness to have NOTES procedure videotaped.
* For sites performing transvaginal NOTES approach - Female subjects only
* Willingness to have cholecystectomy performed via NOTES transvaginal approach.
* Willingness to have intra-abdominal procedure digitally recorded.
* Pelvic examination in the past 12 months without significant pathology.
Exclusion Criteria
* Obese patients (BMI \> 35).
* Patients with severe medical comorbidities (ie, NOT ASA Class 1 or 2) will be excluded such as:
* Chronic renal failure
* Chronic liver disease
* Congestive heart failure
* Patients with a presumed gallbladder malignancy.
* Patients with a history of prior open abdominal or laparoscopic or transvaginal surgery. However patients with prior appendectomy, tubal ligation or Cesarean section will be included.
* Patients who are taking immunosuppressive medications and/or immunocompromised.
* Patients with a prior history of perineal trauma leading to significant alteration of vaginal anatomy.
* Patients with a history of ectopic pregnancy, pelvic inflammatory disease, large fibroids or severe endometriosis.
* Patients with known common bile duct stones. (ie, not cleared prior to surgery). Patients with common bile duct stones discovered intra-operatively will remain in the study.
* Patients on anticoagulation drugs other than once daily aspirin. Abnormal blood coagulation tests. Minimal abnormalities may be allowed at the discretion of site principal investigator.
* Gallstones\> 2.5cm in diameter.
* Presence of untreated esophageal stricture.
* Surgically altered gastric anatomy or severe uncorrected paraesophageal types 2, 3 or 4.
* Unwillingness to consent to NOTES procedure(s).
* Acute cholecystitis or cholangitis
* For sites performing transgastric NOTES approach
* Contraindicated for esophagogastroduodenoscopy (EGD).
* Patients with hypersecretory states.
18 Years
75 Years
ALL
Yes
Sponsors
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American Society for Gastrointestinal Endoscopy
OTHER
Natural Orifice Surgery Consortium for Assessment and Research
OTHER
Responsible Party
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Principal Investigators
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Steven Schwaitzberg, MD
Role: PRINCIPAL_INVESTIGATOR
Cambridge Health Alliance
Michael L. Kochman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Ohio State University
Columbus, Ohio, United States
Oregon Clinic
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Santiago Horgan, MD
Role: primary
Mark Talamini, MD
Role: backup
Kurt Roberts, MD
Role: primary
Eric Hungness, MD
Role: primary
John Romanelli, MD
Role: primary
David Earle, MD
Role: backup
Jeffrey Hazey, MD
Role: primary
Lee Swanstrom, MD
Role: primary
Related Links
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NOSCAR web site
Other Identifiers
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NOTES® Trial
Identifier Type: -
Identifier Source: org_study_id