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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077115
First Posted: February 26, 2010
Last Update Posted: February 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical School of Podgorica, Montenegro
General Hospital Berane, Montenegro
Information provided by:
Ministry of Health, Montenegro
  Purpose
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.

Condition Intervention
Chronic Calculous Cholecystitis Procedure: Laparoscopic cholecystectomy Procedure: Open Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Montenegro:

Primary Outcome Measures:
  • 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


Enrollment: 120
Study Start Date: June 2003
Study Completion Date: September 2006
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic cholecystectomy Procedure: Laparoscopic cholecystectomy
Active Comparator: Open cholecystectomy Procedure: Open Surgery

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Calculous Cholecystitis

Exclusion Criteria:

  • Previous Biliary Surgery
  • Cholangitis
  • Obstructive jaundice
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077115


Locations
Montenegro
Ministry of Health
Podgorica, Montenegro, 81000
Sponsors and Collaborators
Ministry of Health, Montenegro
Medical School of Podgorica, Montenegro
General Hospital Berane, Montenegro
Investigators
Principal Investigator: Miodrag Radunovic, MD, PhD Ministry of Health, Republic of Montenegro
  More Information

Publications:

Responsible Party: Dr Miodrag Radunovic, MD, PhD, Ministry of Health, Montenegro
ClinicalTrials.gov Identifier: NCT01077115     History of Changes
Other Study ID Numbers: MOHMNE001
First Submitted: February 25, 2010
First Posted: February 26, 2010
Last Update Posted: February 26, 2010
Last Verified: February 2010

Keywords provided by Ministry of Health, Montenegro:
Cholecystectomy
Cholecystitis
Laparoscopy
Cholelithiasis
Operative trauma

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases