Cholelithiasis
Conditions
Keywords
Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal
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.
Interventions
PROCEDURELaparoscopic-assisted transvaginal cholecystectomy
Trans-vaginal Cholecystectomy with Laparoscopic Assistance
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and efficacy of the procedure | one year |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative pain | one year |
| Time to return to work | one year |
| Time to return to daily activities | one year |
Countries
United States
Outcome results
None listed