Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Chronic Calculous Cholecystitis Biliary Tract Diseases Cholecystitis Cholelithiasis Digestive System Diseases Gallbladder Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health

Podgorica, 81000, Montenegro

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic Calculous Cholecystitis

Exclusion criteria

Previous Biliary Surgery
Cholangitis
Obstructive jaundice

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Open Surgery

Procedure

Primary outcomes

To determine biohumoral and endocrine parameters of response to trauma

Time frame: 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

Sponsors and collaborators

Lead sponsor

Ministry of Health, Montenegro

Other Gov

Collaborators

General Hospital Berane, Montenegro
Medical School of Podgorica, Montenegro

Registry information

Acronym: ESTOLC

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2006
First posted: Feb 26, 2010
Registry last updated: Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed