Status:
COMPLETED
Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
Lead Sponsor:
Hospital Son Llatzer
Conditions:
Cholelithiasis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).
Detailed Description
Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present ti...
Eligibility Criteria
Inclusion
- age over 18 and under 65
- symptomatic cholelithiasis with an indication for performing laparoscopic surgery
- absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
- perforated hymen
- agreement on the patient's part not to use the vagina for two weeks after the surgery
- signed specific informed consent upon providing specific information about the new surgical approach.
Exclusion
- age under 18 or over 65
- unperforated hymen
- presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00835250
Start Date
February 1 2009
End Date
April 1 2012
Last Update
March 12 2013
Active Locations (1)
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1
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain, 07140