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

Not Applicable
Completed
Conditions
Cholelithiasis
Inflammatory Response
Interventions
Other: Single incision laparoscopic cholecystectomy
Other: Laparoscopic cholecystectomy
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.

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
Arm && Interventions
GroupInterventionDescription
SILS groupSingle incision laparoscopic cholecystectomyPatients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy
Lap GroupLaparoscopic cholecystectomyPatients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

"G. Hatzikosta" General Hospital of Ioannina

🇬🇷

Ioannina, Greece

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