Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
1 other identifier
interventional
200
1 country
6
Brief Summary
This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative outcomes will be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 2, 2011
November 1, 2011
1.9 years
July 26, 2010
November 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
4 weeks post surgery
Secondary Outcomes (1)
To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
4 weeks post surgery
Study Arms (2)
NOTES(R) Cholecystectomy
EXPERIMENTALNatural Orifice Translumenal Endoscopic Surgery techniques
Laparoscopic Cholecystectomy
ACTIVE COMPARATORLaparoscopic Cholecystectomy
Interventions
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.
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
You may qualify if:
- Competent male or female subjects, between the ages of 18-75 and who present for elective cholecystectomy will be offered participation in this study.
- 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.
You may not qualify if:
- Pregnant women.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of California at San Diego
San Diego, California, 92103-8400, United States
Yale University
New Haven, Connecticut, 06520, United States
Northwestern University
Chicago, Illinois, 60611, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Ohio State University
Columbus, Ohio, 43212, United States
Oregon Clinic
Portland, Oregon, 97213, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Schwaitzberg, MD
Cambridge Health Alliance
- PRINCIPAL INVESTIGATOR
Michael L. Kochman, MD
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2010
First Posted
July 28, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
December 2, 2011
Record last verified: 2011-11