Recruiting

NOTES® Cholecystectomy

Sponsor:

Natural Orifice Surgery Consortium for Assessment and Research

Code:

NCT01171027

Conditions

Gall Bladder Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

NOTES Cholecystectomy

Laparoscopic Cholecystectomy

Study Details

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.

Conditions

Gall Bladder Diseases

Study ID

NCT01171027

Start date

Jul, 2010

Status verified date

Nov, 2011

Completion date

Sep, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NOTES(R) Cholecystectomy

Natural Orifice Translumenal Endoscopic Surgery techniques

active comparator: Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy

Interventions

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.

Primary outcome measure

  • To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy. [ Time Frame: 4 weeks post surgery ]

Central Contacts and Locations

Central contacts

Michael Kochman, MD

215 662 4279michael.kochman@uphs.upenn.edu

Steven L Schwaitzberg, MD

617 665 3193sschwaitzberg@challiance.org

Locations

University of California at San Diego

Recruiting

San Diego, California, United States, 92103-8400

Contacts

Santiago Horgan, MD

619-543-2379shorgan@ucsd.edu

Mark Talamini, MD

(619) 543-2379talamini@ucsd.edu

Principal Investigator:

Santiago Horgan, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator:

Kurt Roberts, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Eric Hungness, MD

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

John Romanelli, MD

413-794-5164john.romanelli@baystatehealth.org

David Earle, MD

413-794-5164david.earle@baystatehealth.org

Principal Investigator:

John Romanelli, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Oregon Clinic

Recruiting

Portland, Oregon, United States, 97213

Contacts

Lee Swanstrom, MD

lswanstrom@aol.com

Principal Investigator:

Lee Swanstrom, MD

More Information

Sponsor

Natural Orifice Surgery Consortium for Assessment and Research

Last update posted

Dec 2, 2011

Last verified

Nov, 2011

Keywords

  • Cholecystectomy
  • NOTES
  • Transvaginal
  • Transgastric
  • Natural orifice
  • Gallbladder removal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Natural Orifice Surgery Consortium for Assessment and Research on 2011-12-02.