Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis (Lap vs SILS)

G. Hatzikosta General Hospital

Status: Completed

Conditions: Cholelithiasis; Inflammatory Response

Treatments: Other: Single incision laparoscopic cholecystectomy; Other: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01116492

GH-1948-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Lap Group

Active Comparator group

Description:

Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy

Treatment:

Other: Laparoscopic cholecystectomy

SILS group

Active Comparator group

Description:

Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy

Treatment:

Other: Single incision laparoscopic cholecystectomy