Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Gall Bladder Diseases
• Intervention / Treatment: Procedure: NOTES Cholecystectomy; Procedure: Laparoscopic Cholecystectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Kochman, MD; Phone Number: 215 662 4279; Email: michael.kochman@uphs.upenn.edu
• Study Contact Backup: Name: Steven L Schwaitzberg, MD; Phone Number: 617 665 3193; Email: sschwaitzberg@challiance.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103-8400
      • Recruiting
      • University of California at San Diego
      • Contact: Santiago Horgan, MD; Phone Number: 619-543-2379; Email: shorgan@ucsd.edu
      • Contact: Mark Talamini, MD; Phone Number: (619) 543-2379; Email: talamini@ucsd.edu
      • Principal Investigator: Santiago Horgan, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
      • Contact: Kurt Roberts, MD
      • Principal Investigator: Kurt Roberts, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Eric Hungness, MD
      • Principal Investigator: Eric Hungness, MD
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Contact: John Romanelli, MD; Phone Number: 413-794-5164; Email: john.romanelli@baystatehealth.org
      • Contact: David Earle, MD; Phone Number: 413-794-5164; Email: david.earle@baystatehealth.org
      • Principal Investigator: John Romanelli, MD
      • Sub-Investigator: David Earle, MD
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Ohio State University
      • Contact: Jeffrey Hazey, MD
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Oregon Clinic
      • Contact: Lee Swanstrom, MD; Email: lswanstrom@aol.com
      • Principal Investigator: Lee Swanstrom, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.	4 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.	4 weeks post surgery

Collaborators and Investigators

• Sponsor: Natural Orifice Surgery Consortium for Assessment and Research
• Collaborators: American Society for Gastrointestinal Endoscopy
• Investigators: Principal Investigator: Steven Schwaitzberg, MD, Cambridge Health Alliance; Principal Investigator: Michael L. Kochman, MD, University of Pennsylvania

Publications and helpful links

Helpful Links

• NOSCAR web site

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 2, 2011
• Last Update Submitted That Met QC Criteria: November 30, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Cholecystectomy; NOTES; Transvaginal; Transgastric; Natural orifice; Gallbladder removal
• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Biliary Tract Diseases; Urinary Bladder Diseases; Gallbladder Diseases
• Other Study ID Numbers: NOTES® Trial