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

This study has been completed.
Sponsor:
Collaborators:
Medical School of Podgorica, Montenegro
General Hospital Berane, Montenegro
Information provided by:
Ministry of Health, Montenegro
ClinicalTrials.gov Identifier:
NCT01077115
First received: February 25, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Calculous Cholecystitis

Exclusion Criteria:

  • Previous Biliary Surgery
  • Cholangitis
  • Obstructive jaundice
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Montenegro: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013