Skip to content

Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01077115
Acronym
ESTOLC
Enrollment
120
Registered
2010-02-26
Start date
2003-06-30
Completion date
2006-09-30
Last updated
2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Calculous Cholecystitis

Keywords

Cholecystectomy, Cholecystitis, Laparoscopy, Cholelithiasis, Operative trauma

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.

Interventions

PROCEDURELaparoscopic cholecystectomy
PROCEDUREOpen Surgery

Sponsors

Medical School of Podgorica, Montenegro
CollaboratorUNKNOWN
General Hospital Berane, Montenegro
CollaboratorUNKNOWN
Ministry of Health, Montenegro
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Chronic Calculous Cholecystitis

Exclusion criteria

* Previous Biliary Surgery * Cholangitis * Obstructive jaundice

Design outcomes

Primary

MeasureTime frameDescription
To determine biohumoral and endocrine parameters of response to traumafirst 24h after the surgical interventionUrine 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

Countries

Montenegro

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026