Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Chronic Calculous Cholecystitis
• Interventions: Procedure: Laparoscopic cholecystectomy; Procedure: Open Surgery

• Registration Number: NCT01077115
• Lead Sponsor: Ministry of Health, Montenegro

Brief Summary

The aim of this work is to evaluate which of the two types of operation (traditional/open and laparoscopic) has more impact on patients who were operated electively due to their chronic calculous cholecystitis.

Detailed Description

The prospective, single center, randomized study includes 120 patients who are operated electively - 60 patients operated laparoscopically and 60 patients operated traditionally. Biohumoral and endocrine parameters of response to trauma are determined from 24 hour urine and blood: adrenalin, noradrenalin, metabolites of corticosteroid hormone - 17- hydroxyl and 17- keto steroid (HPLC method), C reactive protein and albumin, glycemia, creatine phosphokinase, lactate dehydrogenase, sedimentation of erythrocytes and serum concentration of potassium.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-06
• Study Completion: 2006-09
• Status Verified: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Last Update Submitted: 2010-02-25
• Study First Posted: 2010-02-26
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Chronic Calculous Cholecystitis

Exclusion Criteria

• Previous Biliary Surgery
• Cholangitis
• Obstructive jaundice

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic cholecystectomy	Laparoscopic cholecystectomy	-
Open cholecystectomy	Open Surgery	-

Primary Outcome Measures

Name	Time	Method
To determine biohumoral and endocrine parameters of response to trauma	first 24h after the surgical intervention	Urine and blood biochemical analyses: adrenalin, noradrenalin, metabolites of corticosteroid hormone - 17- hydroxyl and 17- keto steroid (HPLC method), C reactive protein and albumin, glycemia, creatine phosphokinase, lactate dehydrogenase, sedimentation of erythrocytes and serum concentration of potassium

Trial Locations

Locations (1)

Ministry of Health; 🇲🇪 Podgorica, Montenegro