Status:
COMPLETED
Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
Lead Sponsor:
Universidad Juárez del Estado de Durango
Collaborating Sponsors:
Hospital Universitario La Paz
Conditions:
Cholelithiasis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been e...
Detailed Description
Most recently, surgeons and endoscopists have focused on NOTES cholecystectomy. Access to the abdominal cavity to perform NOTES procedures has been obtained by transgastric, transvaginal, transvesical...
Eligibility Criteria
Inclusion
- Adult (\> 18 years old) female patients residents of Durango Mexico.
- Patients who undergo elective surgery.
- Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
- Patients capable of giving written informed consent for the study.
Exclusion
- Patients who have contraindications prohibiting general anesthesia.
- Pregnancy.
- Previous abdominal or gynecological procedures.
- Uncontrollable medical or psychiatric conditions
- Elderly \> 65 y/o.
- Body Mass Index \> 35 mg/kg2.
- Complicated or acute cholecystitis.
- Elevation of liver function tests.
- Acute abdomen.
- Intra-abdominal abscess.
- Coagulopathy.
- Imperforated hymen.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00710502
Start Date
January 1 2009
End Date
December 1 2009
Last Update
December 15 2009
Active Locations (1)
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1
Universidad Juarez del Estado de Durango, Mexico
Durango, Durango, Mexico, 34000