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
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal
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
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
NCT ID
NCT00910325
First Posted
May 27, 2009
Last Updated
October 29, 2012
Sponsor
Massachusetts General Hospital
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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