Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Mass General Brigham

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Cholelithiasis

Treatments: Procedure: Laparoscopic-assisted transvaginal cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00910325

2008p001938

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 26 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)