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Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Primary Purpose

Cholelithiasis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic-assisted transvaginal cholecystectomy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal

Eligibility Criteria

26 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females who are postmenopausal or who no longer wish to bear children
  • Females >25 years old and <65 years old
  • Diagnosis of biliary disease requiring cholecystectomy
  • American Society of Anesthesiology (ASA) Class I or II
  • Females who are able to understand and willing to sign an informed consent document

Exclusion Criteria:

  • Pregnancy
  • BMI >= 30
  • Patients who are still interested in childbearing
  • Patients taking immunosuppressive medications or who are immunocompromised
  • Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
  • Patients with suspicion of gallbladder cancer
  • Patients with history of previous open abdominal surgery
  • Patients with untreated common bile duct stones

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

The safety and efficacy of the procedure

Secondary Outcome Measures

Post-operative pain
Time to return to work
Time to return to daily activities

Full Information

First Posted
May 27, 2009
Last Updated
October 29, 2012
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00910325
Brief Title
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Official Title
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic-assisted transvaginal cholecystectomy
Intervention Description
Trans-vaginal Cholecystectomy with Laparoscopic Assistance
Primary Outcome Measure Information:
Title
The safety and efficacy of the procedure
Time Frame
one year
Secondary Outcome Measure Information:
Title
Post-operative pain
Time Frame
one year
Title
Time to return to work
Time Frame
one year
Title
Time to return to daily activities
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females who are postmenopausal or who no longer wish to bear children Females >25 years old and <65 years old Diagnosis of biliary disease requiring cholecystectomy American Society of Anesthesiology (ASA) Class I or II Females who are able to understand and willing to sign an informed consent document Exclusion Criteria: Pregnancy BMI >= 30 Patients who are still interested in childbearing Patients taking immunosuppressive medications or who are immunocompromised Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid) Patients with suspicion of gallbladder cancer Patients with history of previous open abdominal surgery Patients with untreated common bile duct stones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Rattner, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

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