Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
Phase 1
Terminated
- Conditions
- Cholelithiasis
- Registration Number
- NCT00910325
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 3
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The safety and efficacy of the procedure one year
- Secondary Outcome Measures
Name Time Method Post-operative pain one year Time to return to work one year Time to return to daily activities one year
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital🇺🇸Boston, Massachusetts, United States