Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00910325
• Other study ID #: 2008p001938
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 27, 2009
• Last updated: October 29, 2012
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 26 Years to 64 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Laparoscopic-assisted transvaginal cholecystectomy
Trans-vaginal Cholecystectomy with Laparoscopic Assistance

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and efficacy of the procedure		one year	Yes
Secondary	Post-operative pain		one year	No
Secondary	Time to return to work		one year	No
Secondary	Time to return to daily activities		one year	No