Clinical Trials Directory

Trials / Completed

CompletedNCT01077115

Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Ministry of Health, Montenegro · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic cholecystectomy
PROCEDUREOpen Surgery

Timeline

Start date
2003-06-01
Primary completion
2004-06-01
Completion
2006-09-01
First posted
2010-02-26
Last updated
2010-02-26

Locations

1 site across 1 country: Montenegro

Source: ClinicalTrials.gov record NCT01077115. Inclusion in this directory is not an endorsement.