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

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ClinicalTrials.gov Identifier: NCT01077115
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Collaborators:
Medical School of Podgorica, Montenegro
General Hospital Berane, Montenegro
Information provided by:
Ministry of Health, Montenegro

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Calculous Cholecystitis Procedure: Laparoscopic cholecystectomy Procedure: Open Surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
Study Start Date : June 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : September 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopic cholecystectomy Procedure: Laparoscopic cholecystectomy
Active Comparator: Open cholecystectomy Procedure: Open Surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Montenegro
Ministry of Health
Podgorica, Montenegro, 81000
Sponsors and Collaborators
Ministry of Health, Montenegro
Medical School of Podgorica, Montenegro
General Hospital Berane, Montenegro
Investigators
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Principal Investigator: Miodrag Radunovic, MD, PhD Ministry of Health, Republic of Montenegro
More Information
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Publications:

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Responsible Party: Dr Miodrag Radunovic, MD, PhD, Ministry of Health, Montenegro
ClinicalTrials.gov Identifier: NCT01077115    
Other Study ID Numbers: MOHMNE001
First Posted: February 26, 2010    Key Record Dates
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:
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Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases