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

Primary Purpose

Chronic Calculous Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Montenegro
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Open Surgery
Sponsored by
Ministry of Health, Montenegro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Calculous Cholecystitis focused on measuring Cholecystectomy, Cholecystitis, Laparoscopy, Cholelithiasis, Operative trauma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic Calculous Cholecystitis

Exclusion Criteria:

  • Previous Biliary Surgery
  • Cholangitis
  • Obstructive jaundice

Sites / Locations

  • Ministry of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic cholecystectomy

Open cholecystectomy

Arm Description

Outcomes

Primary Outcome Measures

To determine biohumoral and endocrine parameters of response to trauma
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

Secondary Outcome Measures

Full Information

First Posted
February 25, 2010
Last Updated
February 25, 2010
Sponsor
Ministry of Health, Montenegro
Collaborators
Medical School of Podgorica, Montenegro, General Hospital Berane, Montenegro
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1. Study Identification

Unique Protocol Identification Number
NCT01077115
Brief Title
Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
Acronym
ESTOLC
Official Title
Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Montenegro
Collaborators
Medical School of Podgorica, Montenegro, General Hospital Berane, Montenegro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Calculous Cholecystitis
Keywords
Cholecystectomy, Cholecystitis, Laparoscopy, Cholelithiasis, Operative trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic cholecystectomy
Arm Type
Experimental
Arm Title
Open cholecystectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Open Surgery
Primary Outcome Measure Information:
Title
To determine biohumoral and endocrine parameters of response to trauma
Description
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
Time Frame
first 24h after the surgical intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Calculous Cholecystitis Exclusion Criteria: Previous Biliary Surgery Cholangitis Obstructive jaundice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miodrag Radunovic, MD, PhD
Organizational Affiliation
Ministry of Health, Republic of Montenegro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health
City
Podgorica
ZIP/Postal Code
81000
Country
Montenegro

12. IPD Sharing Statement

Citations:
PubMed Identifier
8392916
Citation
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Results Reference
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PubMed Identifier
16186960
Citation
Crema E, Ribeiro EN, Hial AM, Alves Junior JT, Pastore R, Silva AA. Evaluation of the response of cortisol, corticotropin and blood platelets kinetics after laparoscopic and open cholecystectomy. Acta Cir Bras. 2005 Sep-Oct;20(5):364-7. doi: 10.1590/s0102-86502005000500005. Epub 2005 Sep 5.
Results Reference
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PubMed Identifier
11905180
Citation
Mrksic M, Cabafi Z, Feher I, Mirkovic M. [Surgical trauma in laparoscopic and classical cholecystectomy]. Med Pregl. 2001 Jul-Aug;54(7-8):327-31. Croatian.
Results Reference
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PubMed Identifier
16334446
Citation
Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. doi: 10.1080/00365520510023675.
Results Reference
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PubMed Identifier
15513364
Citation
Ros A, Nilsson E. Abdominal pain and patient overall and cosmetic satisfaction one year after cholecystectomy: outcome of a randomized trial comparing laparoscopic and minilaparotomy cholecystectomy. Scand J Gastroenterol. 2004 Aug;39(8):773-7. doi: 10.1080/00365520410005540.
Results Reference
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PubMed Identifier
16022643
Citation
Schirmer BD, Winters KL, Edlich RF. Cholelithiasis and cholecystitis. J Long Term Eff Med Implants. 2005;15(3):329-38. doi: 10.1615/jlongtermeffmedimplants.v15.i3.90.
Results Reference
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PubMed Identifier
15973772
Citation
Chen L, Tao SF, Xu Y, Fang F, Peng SY. Patients' quality of life after laparoscopic or open cholecystectomy. J Zhejiang Univ Sci B. 2005 Jul;6(7):678-81. doi: 10.1631/jzus.2005.B0678.
Results Reference
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PubMed Identifier
15557357
Citation
Nilsson E, Ros A, Rahmqvist M, Backman K, Carlsson P. Cholecystectomy: costs and health-related quality of life: a comparison of two techniques. Int J Qual Health Care. 2004 Dec;16(6):473-82. doi: 10.1093/intqhc/mzh077.
Results Reference
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PubMed Identifier
8286176
Citation
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Results Reference
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PubMed Identifier
6542833
Citation
Hakanson E, Rutberg H, Jorfeldt L, Wiklund L. Endocrine and metabolic responses after standardized moderate surgical trauma: influence of age and sex. Clin Physiol. 1984 Dec;4(6):461-73. doi: 10.1111/j.1475-097x.1984.tb00132.x.
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PubMed Identifier
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Citation
Mealy K, Gallagher H, Barry M, Lennon F, Traynor O, Hyland J. Physiological and metabolic responses to open and laparoscopic cholecystectomy. Br J Surg. 1992 Oct;79(10):1061-4. doi: 10.1002/bjs.1800791024.
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Citation
Kiviluoto T, Siren J, Luukkonen P, Kivilaakso E. Randomised trial of laparoscopic versus open cholecystectomy for acute and gangrenous cholecystitis. Lancet. 1998 Jan 31;351(9099):321-5. doi: 10.1016/S0140-6736(97)08447-X.
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

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