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

Ministry of Health, Montenegro

Status: Completed

Conditions: Chronic Calculous Cholecystitis

Treatments: Procedure: Laparoscopic cholecystectomy; Procedure: Open Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01077115

MOHMNE001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Calculous Cholecystitis

Exclusion criteria

• Previous Biliary Surgery
• Cholangitis
• Obstructive jaundice

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Laparoscopic cholecystectomy

Experimental group

Treatment:

Procedure: Laparoscopic cholecystectomy

Open cholecystectomy

Active Comparator group

Treatment:

Procedure: Open Surgery