Status:
COMPLETED
Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic
Lead Sponsor:
Yale University
Conditions:
Biliary Colic
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
A safe and effective transvaginal approach accessing the abdominal cavity through the vagina rather than the abdominal wall is today considered a routine approach for many gynecologic surgeries. Firs...
Eligibility Criteria
Inclusion
- Female.
- Age between 18 and 65 years old.
- Biliary dyskinesia with documented Gallbladder EF \< 30% or diagnosis of biliary colic with documented gallstones or polyps by imaging.
- Body Mass Index (BMI) \< 45 kg/m2.
Exclusion
- Any female patient, who is pregnant, suspected pregnant, or lactating.
- Any patient with acute or acalculous cholecystitis.
- Any patient with an American Society of Anesthesiologists Score \> 3.
- Any patient who is undergoing Peritoneal Dialysis (PD).
- Patients who are taking immunosuppressive medications or are immunocompromised.
- Patients on blood thinners or aspirin or abnormal blood coagulation tests.
- Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
- Patients with a history of ectopic pregnancy, pelvic inflammatory disease (PID) or severe endometriosis.
- Non English speaking patients.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00963950
Start Date
August 1 2009
End Date
March 1 2014
Last Update
January 17 2018
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