Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Chronic Calculous Cholecystitis Clinical Trial

— ESTOLC  

Official title:

Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077115
• Other study ID #: MOHMNE001
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: February 25, 2010
• Start date: June 2003
• Est. completion date: September 2006

Study information

• Verified date: February 2010
• Source: Ministry of Health, Montenegro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Montenegro: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2006
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Chronic Calculous Cholecystitis

Exclusion Criteria:

• Previous Biliary Surgery

• Cholangitis

• Obstructive jaundice

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Chronic Calculous Cholecystitis

Intervention

Procedure:
• Laparoscopic cholecystectomy

• Open Surgery

Locations

Country	Name	City	State
Montenegro	Ministry of Health	Podgorica

Sponsors (3)

Lead Sponsor	Collaborator
Ministry of Health, Montenegro	General Hospital Berane, Montenegro, Medical School of Podgorica, Montenegro

Country where clinical trial is conducted

Montenegro, 

References & Publications (15)

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. — View Citation

Baxter JN, O'Dwyer PJ. Pathophysiology of laparoscopy. Br J Surg. 1995 Jan;82(1):1-2. — View Citation

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. — View Citation

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. — View Citation

Crema E, Ribeiro EN, Hial AM, Alves Júnior 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. Epub 2005 Sep 5. — View Citation

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. — View Citation

Håkanson 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. — View Citation

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. — View Citation

Kiviluoto T, Sirén 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. — View Citation

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. — View Citation

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. — View Citation

Nilsson E, Ros A, Rahmqvist M, Bäckman 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. — View Citation

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. — View Citation

Schirmer BD, Winters KL, Edlich RF. Cholelithiasis and cholecystitis. J Long Term Eff Med Implants. 2005;15(3):329-38. Review. — View Citation

Udelsman R, Chrousos GP. Hormonal responses to surgical stress. Adv Exp Med Biol. 1988;245:265-72. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes