Gallbladder retractor and Knot pusher with simultaneous coaxial traction : new laparoscopic instruments.

Phase 3

• Conditions: Symptomatic chronic cholelithiasis; Cholecystolithiasis; Cholelithiasis; Gallbladder Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

• Registration Number: RPCEC00000019
• Lead Sponsor: ational Center for Minimal Access Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients older than 15 years-old, both gender, with diagnosis of symptomatic chronic cholelithiasis tributary of surgical treatment.

Exclusion Criteria

PREOPERATIVE: -History of acute cholecystitis -History of cholangitis or bile duct calculus -History of pancreatitis -Hepatic cirrhosis associated -Morbid obesity -Acute cholecystitis -Clinical, chemical and/or echographic criteria for intraoperative cholangiographie -An added proposed surgical procedure DURING INITIAL LAPAROEXPLORATION: -Cancer of gallbladder -Severe inflammation of gallbladder -Extensive adhesions in abdominal right quadrant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-Gallbladder’s fundus retraction”, timepoint: at the end of surgical procedure. Asses the efficacy of GR as retraction device for vesicular fundus. 2-Placement of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP to place endo-loops sutures to retract and expose the neck of gallbladder. 3-Sliding of endo-loops sutures”, timepoint: at the end of surgical procedure. Asses the efficacy of KP, because it has influence on adequate surgical technique. 4- Success on the technique of cholecystectomy proposed”, timepoint: at the end of surgical procedure. Asses the general efficacy of both instruments.

Secondary Outcome Measures

Name	Time	Method
- Operative time”, timepoint: at the end of surgical procedure. - CO2 consumption”, timepoint: at the end of surgical procedure. - Adverse events related to the use of designed instruments”, timepoint: at the end of surgical procedure. - Cosmetic results”, timepoint: at the follow-up, on 10-15 days before surgical procedure. - Cost of surgical procedure”, timepoint: at the end of hospital stay.