Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

Not Applicable

Completed

• Conditions: Cholelithiasis; Inflammatory Response

• Registration Number: NCT01116492
• Lead Sponsor: G. Hatzikosta General Hospital

Brief Summary

This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

Detailed Description

Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Last Update Submitted: 2010-05-20
• Last Update Posted: 2010-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Uncomplicated cholelithiasis
• American Society of Anesthesiologists (ASA) I or II
• No previous operations in upper abdomen
• Body mass index (BMI) <30

Exclusion Criteria

• Cholecystitis
• ASA > II
• BMI>30
• Previous operations in upper abdomen
• Previous operations in intestine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

"G. Hatzikosta" General Hospital of Ioannina; 🇬🇷 Ioannina, Greece