Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

This study has been terminated.
(The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative)
Sponsor:
Information provided by (Responsible Party):
David W. Rattner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00910325
First received: May 27, 2009
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Cholelithiasis
Procedure: Laparoscopic-assisted transvaginal cholecystectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The safety and efficacy of the procedure [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-operative pain [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time to return to work [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time to return to daily activities [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: November 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Laparoscopic-assisted transvaginal cholecystectomy
    Trans-vaginal Cholecystectomy with Laparoscopic Assistance
  Eligibility

Ages Eligible for Study:   26 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910325

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David W Rattner, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David W. Rattner, MD, Chief, Division of General and Gastrointestinal Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00910325     History of Changes
Other Study ID Numbers: 2008p001938
Study First Received: May 27, 2009
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Female
Cholelithiasis
Natural Orifice Surgery
Laparoscopic- Assisted
Transvaginal

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014