Clinical trial NCT01077115: Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
Official title: Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Calculous Cholecystitis
Keywords: Cholecystectomy
Cholecystitis
Laparoscopy
Cholelithiasis
Operative trauma
Lead sponsor: Ministry of Health, Montenegro
Sponsor class: OTHER_GOV
Collaborators: name: Medical School of Podgorica, Montenegro
name: General Hospital Berane, Montenegro
First posted: 2010-02-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Chronic Calculous Cholecystitis

Exclusion Criteria:

* Previous Biliary Surgery
* Cholangitis
* Obstructive jaundice

Primary outcomes:
measure: To determine biohumoral and endocrine parameters of response to trauma
timeFrame: first 24h after the surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Podgorica
country: Montenegro
facility: Ministry of Health
Study officials:
affiliation: Ministry of Health, Republic of Montenegro
name: Miodrag Radunovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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