Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Natural Orifice Surgery Consortium for Assessment and Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
Natural Orifice Surgery Consortium for Assessment and Research
ClinicalTrials.gov Identifier:
NCT01171027
First received: July 26, 2010
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Gall Bladder Diseases
Procedure: NOTES Cholecystectomy
Procedure: Laparoscopic Cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Natural Orifice Surgery Consortium for Assessment and Research:

Primary Outcome Measures:
  • To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy. [ Time Frame: 4 weeks post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy. [ Time Frame: 4 weeks post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOTES(R) Cholecystectomy
Natural Orifice Translumenal Endoscopic Surgery techniques
Procedure: 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.
Active Comparator: Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Procedure: 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.
Procedure: 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.

Detailed Description:

Primary To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171027

Contacts
Contact: Michael Kochman, MD 215 662 4279 michael.kochman@uphs.upenn.edu
Contact: Steven L Schwaitzberg, MD 617 665 3193 sschwaitzberg@challiance.org

Locations
United States, California
University of California at San Diego Recruiting
San Diego, California, United States, 92103-8400
Contact: Santiago Horgan, MD    619-543-2379    shorgan@ucsd.edu   
Contact: Mark Talamini, MD    (619) 543-2379    talamini@ucsd.edu   
Principal Investigator: Santiago Horgan, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kurt Roberts, MD         
Principal Investigator: Kurt Roberts, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric Hungness, MD         
Principal Investigator: Eric Hungness, MD         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: John Romanelli, MD    413-794-5164    john.romanelli@baystatehealth.org   
Contact: David Earle, MD    413-794-5164    david.earle@baystatehealth.org   
Principal Investigator: John Romanelli, MD         
Sub-Investigator: David Earle, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43212
Contact: Jeffrey Hazey, MD         
United States, Oregon
Oregon Clinic Recruiting
Portland, Oregon, United States, 97213
Contact: Lee Swanstrom, MD       lswanstrom@aol.com   
Principal Investigator: Lee Swanstrom, MD         
Sponsors and Collaborators
Natural Orifice Surgery Consortium for Assessment and Research
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Steven Schwaitzberg, MD Cambridge Health Alliance
Principal Investigator: Michael L. Kochman, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Natural Orifice Surgery Consortium for Assessment and Research
ClinicalTrials.gov Identifier: NCT01171027     History of Changes
Other Study ID Numbers: NOTES® Trial
Study First Received: July 26, 2010
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Natural Orifice Surgery Consortium for Assessment and Research:
Cholecystectomy
NOTES
Transvaginal
Transgastric
Natural orifice
Gallbladder removal

Additional relevant MeSH terms:
Urinary Bladder Diseases
Gallbladder Diseases
Urologic Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014