Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy (ESTOLC)

February 25, 2010 updated by: Ministry of Health, Montenegro
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Montenegro
      • Podgorica, Montenegro, 81000
        • Ministry of health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic Calculous Cholecystitis

Exclusion Criteria:

  • Previous Biliary Surgery
  • Cholangitis
  • Obstructive jaundice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic cholecystectomy
Procedure: Laparoscopic cholecystectomy
Active Comparator: Open cholecystectomy
Procedure: Open Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first 24h after the surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Montenegro

Collaborators

Medical School of Podgorica, Montenegro
General Hospital Berane, Montenegro

Investigators

  • Principal Investigator: Miodrag Radunovic, MD, PhD, Ministry of Health, Republic of Montenegro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 26, 2010

Last Update Submitted That Met QC Criteria

February 25, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOHMNE001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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