NCT01077115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
Last Updated

February 26, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

February 25, 2010

Last Update Submit

February 25, 2010

Conditions

Chronic Calculous Cholecystitis

Keywords

CholecystectomyCholecystitisLaparoscopyCholelithiasisOperative trauma

Outcome Measures

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

    first 24h after the surgical intervention

Study Arms (2)

Laparoscopic cholecystectomy

EXPERIMENTAL
Procedure: Laparoscopic cholecystectomy

Open cholecystectomy

ACTIVE COMPARATOR
Procedure: Open Surgery

Interventions

Laparoscopic cholecystectomyPROCEDURE
Laparoscopic cholecystectomy
Open SurgeryPROCEDURE
Open cholecystectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Calculous Cholecystitis

You may not qualify if:

  • Previous Biliary Surgery
  • Cholangitis
  • Obstructive jaundice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health

Podgorica, 81000, Montenegro

Location

Related Publications (15)

  • 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.

    PMID: 8392916BACKGROUND

  • 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.

    PMID: 16186960BACKGROUND

  • 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.

    PMID: 11905180BACKGROUND

  • 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.

    PMID: 16334446BACKGROUND

  • 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.

    PMID: 15513364BACKGROUND

  • 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.

    PMID: 16022643BACKGROUND

  • 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.

    PMID: 15973772BACKGROUND

  • 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.

    PMID: 15557357BACKGROUND

  • 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.

    PMID: 8286176BACKGROUND

  • 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.

    PMID: 6542833BACKGROUND

  • 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.

    PMID: 1422720BACKGROUND

  • 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.

    PMID: 9652612BACKGROUND

  • 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.

    PMID: 16329083BACKGROUND

  • 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.

    PMID: 2852458BACKGROUND

  • 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.

    PMID: 7881922BACKGROUND

MeSH Terms

Conditions

CholecystitisCholelithiasis

Interventions

Cholecystectomy, LaparoscopicConversion to Open Surgery

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Miodrag Radunovic, MD, PhD

    Ministry of Health, Republic of Montenegro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

June 1, 2003

Primary Completion

June 1, 2004

Study Completion

September 1, 2006

Last Updated

February 26, 2010

Record last verified: 2010-02

Locations

MO(1)