ClinicalTrials.gg
Sign In
CompletedNCT01077115ESTOLCUpdated Feb 26, 2010

Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

An interventional study of Laparoscopic cholecystectomy and Open Surgery in Chronic Calculous Cholecystitis, sponsored by Ministry of Health, Montenegro. Completed at 1 site in Montenegro. Per ClinicalTrials.gov, last updated 2010-02-26.

Sponsored by Ministry of Health, Montenegro · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Calculous Cholecystitis

Keywords

  • Cholecystectomy
  • Cholecystitis
  • Laparoscopy
  • Cholelithiasis
  • Operative trauma
03

In context

Cholecystitis

192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.

This study's enrollment of 120 is above the median of 82 across 129 interventional studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

This is the only study on the registry with Ministry of Health, Montenegro as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic Calculous Cholecystitis

Exclusion criteria

Exclusion Criteria:

  • Previous Biliary Surgery
  • Cholangitis
  • Obstructive jaundice
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Laparoscopic cholecystectomy

    Procedure: Laparoscopic cholecystectomy

  • Active comparator
    Open cholecystectomy

    Procedure: Open Surgery

Interventions

  • ProcedureLaparoscopic cholecystectomy
  • ProcedureOpen Surgery
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: first 24h after the surgical intervention

07

Study locations

1 site
  • Ministry of Health
    Podgorica, 81000, Montenegro
08

References and documents

Publications

  • Donald RA, Perry EG, Wittert GA, Chapman M, Livesey JH, Ellis MJ, Evans MJ, Yandle T, Espiner EA. The plasma ACTH, AVP, CRH and catecholamine responses to conventional and laparoscopic cholecystectomy. Clin Endocrinol (Oxf). 1993 Jun;38(6):609-15. doi: 10.1111/j.1365-2265.1993.tb02142.x. PubMed 8392916 ↗
  • 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. PubMed 16186960 ↗
  • 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. PubMed 11905180 ↗
  • 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. PubMed 16334446 ↗
  • 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. PubMed 15513364 ↗
  • 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. PubMed 16022643 ↗
  • 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. PubMed 15973772 ↗
  • 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. PubMed 15557357 ↗
  • Agnifili A, Ibi I, Guadagni S, Verzaro R, Gianfelice F, Mancini E, De Bernardinis G, Silvi B, Leonardis F. [Perioperative pain and stress: a comparison between video laparoscopic cholecystectomy and "open" cholecystectomy]. G Chir. 1993 Sep;14(7):344-8. Italian. PubMed 8286176 ↗
  • 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. PubMed 6542833 ↗
  • 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. PubMed 1422720 ↗
  • 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. PubMed 9652612 ↗
  • Johansson M, Thune A, Nelvin L, Lundell L. Randomized clinical trial of day-care versus overnight-stay laparoscopic cholecystectomy. Br J Surg. 2006 Jan;93(1):40-5. doi: 10.1002/bjs.5241. PubMed 16329083 ↗
  • Udelsman R, Chrousos GP. Hormonal responses to surgical stress. Adv Exp Med Biol. 1988;245:265-72. doi: 10.1007/978-1-4899-2064-5_21. PubMed 2852458 ↗
  • Baxter JN, O'Dwyer PJ. Pathophysiology of laparoscopy. Br J Surg. 1995 Jan;82(1):1-2. doi: 10.1002/bjs.1800820102. No abstract available. PubMed 7881922 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2003, a primary completion of Jun 2004 and a completion of Sep 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2010
First posted
Feb 26, 2010
Start
Jun 2003
Primary completionActual
Jun 2004
CompletionActual
Sep 2006
Last update
Feb 26, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01077115
Lead sponsor
Ministry of Health, Montenegro
Collaborators
Medical School of Podgorica, Montenegro, General Hospital Berane, Montenegro
First posted
Feb 26, 2010
Start date
Jun 2003
Primary completion
Jun 2004
Completion
Sep 2006
Last update
Feb 26, 2010

Study contacts

Miodrag Radunovic, MD, PhD
principal investigator · Ministry of Health, Republic of Montenegro

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cholecystitis →

Start the discussion