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Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

Primary Purpose

Gall Bladder Diseases

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NOTES Cholecystectomy

Laparoscopic Cholecystectomy

About this trial

This is an interventional treatment trial for Gall Bladder Diseases focused on measuring Cholecystectomy, NOTES, Transvaginal, Transgastric, Natural orifice, Gallbladder removal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of California at San DiegoRecruiting
Yale UniversityRecruiting
Northwestern UniversityRecruiting
Baystate Medical CenterRecruiting
Ohio State UniversityRecruiting
Oregon ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NOTES(R) Cholecystectomy

Laparoscopic Cholecystectomy

Arm Description

Natural Orifice Translumenal Endoscopic Surgery techniques

Laparoscopic Cholecystectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

Full Information

NCT ID

NCT01171027

First Posted

July 26, 2010

Last Updated

November 30, 2011

Sponsor

Natural Orifice Surgery Consortium for Assessment and Research

Collaborators

American Society for Gastrointestinal Endoscopy

1. Study Identification

Unique Protocol Identification Number

NCT01171027

Brief Title

Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

Official Title

Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Natural Orifice Surgery Consortium for Assessment and Research

Collaborators

American Society for Gastrointestinal Endoscopy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gall Bladder Diseases

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NOTES(R) Cholecystectomy

Arm Type

Experimental

Arm Description

Natural Orifice Translumenal Endoscopic Surgery techniques

Arm Title

Laparoscopic Cholecystectomy

Arm Type

Active Comparator

Arm Description

Laparoscopic Cholecystectomy

Intervention Type

Procedure

Intervention Name(s)

NOTES Cholecystectomy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Cholecystectomy

Intervention Description

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 Information:

Title

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

Time Frame

4 weeks post surgery

Secondary Outcome Measure Information:

Title

To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.

Time Frame

4 weeks post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Kochman, MD

Phone

215 662 4279

michael.kochman@uphs.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Steven L Schwaitzberg, MD

Phone

617 665 3193

sschwaitzberg@challiance.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Schwaitzberg, MD

Organizational Affiliation

Cambridge Health Alliance

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael L. Kochman, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California at San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92103-8400

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Santiago Horgan, MD

Phone

619-543-2379

shorgan@ucsd.edu

First Name & Middle Initial & Last Name & Degree

Mark Talamini, MD

Phone

(619) 543-2379

talamini@ucsd.edu

First Name & Middle Initial & Last Name & Degree

Santiago Horgan, MD

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kurt Roberts, MD

First Name & Middle Initial & Last Name & Degree

Kurt Roberts, MD

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Hungness, MD

First Name & Middle Initial & Last Name & Degree

Eric Hungness, MD

Facility Name

Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Romanelli, MD

Phone

413-794-5164

john.romanelli@baystatehealth.org

First Name & Middle Initial & Last Name & Degree

David Earle, MD

Phone

413-794-5164

david.earle@baystatehealth.org

First Name & Middle Initial & Last Name & Degree

John Romanelli, MD

First Name & Middle Initial & Last Name & Degree

David Earle, MD

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey Hazey, MD

Facility Name

Oregon Clinic

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lee Swanstrom, MD

lswanstrom@aol.com

First Name & Middle Initial & Last Name & Degree

Lee Swanstrom, MD

12. IPD Sharing Statement

Links:

URL

http://www.noscar.org

Description

NOSCAR web site

Learn more about this trial

Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

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