Study Stopped
The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 30, 2012
October 1, 2012
3.8 years
May 27, 2009
October 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety and efficacy of the procedure
one year
Secondary Outcomes (3)
Post-operative pain
one year
Time to return to work
one year
Time to return to daily activities
one year
Interventions
Trans-vaginal Cholecystectomy with Laparoscopic Assistance
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David W Rattner, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of General and Gastrointestinal Surgery
Study Record Dates
First Submitted
May 27, 2009
First Posted
May 29, 2009
Study Start
November 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 30, 2012
Record last verified: 2012-10