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

Inflammatory Response Clinical Trial

— Lap vs SILS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116492
• Other study ID #: GH-1948-05
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: May 20, 2010
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: G. Hatzikosta General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Inflammation
• Inflammatory Response

Intervention

Other:
• Single incision laparoscopic cholecystectomy
One port placed through the umbilicus
• Laparoscopic cholecystectomy
Standard 4 port laparoscopic cholecystectomy

Locations

Country	Name	City	State
Greece	"G. Hatzikosta" General Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
G. Hatzikosta General Hospital

Country where clinical trial is conducted

Greece,