Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
NCT ID: NCT00910325
Last Updated: 2012-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
3 participants
INTERVENTIONAL
2008-11-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Laparoscopic-assisted transvaginal cholecystectomy
Trans-vaginal Cholecystectomy with Laparoscopic Assistance
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
26 Years
64 Years
FEMALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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David W. Rattner, MD
Chief, Division of General and Gastrointestinal Surgery
Principal Investigators
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David W Rattner, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2008p001938
Identifier Type: -
Identifier Source: org_study_id