Chronic Calculous CholecystitisESTOLCNCT01077115
Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
A study testing Laparoscopic cholecystectomy and Open Surgery in people with Chronic Calculous Cholecystitis, run by Ministry of Health, Montenegro at 1 site in Montenegro.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Calculous Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy and Open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMontenegro
- Study dates
- Jun 2003to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic Calculous Cholecystitis
Who cannot join
- Previous Biliary Surgery
- Cholangitis
- Obstructive jaundice
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Calculous Cholecystitis
- Being tested
- Laparoscopic cholecystectomy, Open Surgery
- Keywords
- Cholecystectomy, Cholecystitis, Laparoscopy, Cholelithiasis, Operative trauma
- Medical subject headings
- Cholecystitis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Open SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy | Experimental | Not described Receives: Procedure: Laparoscopic cholecystectomy |
| Open cholecystectomy | Active comparator | Not described Receives: Procedure: Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first 24h after the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJun 2003
- Primary completionJun 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Calculous CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Montenegro
- Sponsor type
- Other government
- Collaborators
- Medical School of Podgorica, Montenegro, General Hospital Berane, Montenegro
- Investigators
- Miodrag Radunovic, MD, PhD, Principal investigator, Ministry of Health, Republic of Montenegro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077115
- Sponsor's protocol ID
- MOHMNE001
- Acronym
- ESTOLC
- Status last verified
- Feb 2010
- First submitted
- 25 Feb 2010
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
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 8392916Crema 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 16186960Mrksic 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 11905180Bisgaard 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 16334446Ros 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 15513364Schirmer 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 16022643Chen 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 15973772Nilsson 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 15557357Agnifili 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 8286176Hakanson 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 6542833Mealy 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 1422720Kiviluoto 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 9652612Johansson 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 16329083Udelsman 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 2852458Baxter 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01077115
- Acronym / sponsor ID
- ESTOLC / MOHMNE001
- Conditions
- Chronic Calculous Cholecystitis
- Keywords
- Cholecystectomy, Cholecystitis, Laparoscopy, Cholelithiasis, Operative trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ministry of Health, MontenegroOther government
- Collaborators
- Medical School of Podgorica, Montenegro, General Hospital Berane, Montenegro
- Study start
- Jun 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy | Experimental | Procedure: Laparoscopic cholecystectomy |
| Open cholecystectomy | Active comparator | Procedure: Open Surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Calculous Cholecystitis
Key exclusion criteria (3 listed)
- Previous Biliary Surgery
- Cholangitis
- Obstructive jaundice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomy | Procedure or surgery | Laparoscopic cholecystectomy |
| Open Surgery | Procedure or surgery | Open cholecystectomy |
Primary outcome
To determine biohumoral and endocrine parameters of response to trauma
Time frame: first 24h after the surgical intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Background: PubMed 8392916Donald 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.
- Background: PubMed 16186960Crema 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.
- Background: PubMed 11905180Mrksic 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.
- Background: PubMed 16334446Bisgaard 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.
- Background: PubMed 15513364Ros 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.
- Background: PubMed 16022643Schirmer 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.
- Background: PubMed 15973772Chen 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.
- Background: PubMed 15557357Nilsson 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.
- Background: PubMed 8286176Agnifili 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.
- Background: PubMed 6542833Hakanson 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.
- Background: PubMed 1422720Mealy 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.
- Background: PubMed 9652612Kiviluoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miodrag Radunovic, MD, PhD principal investigator
Ministry of Health, Republic of Montenegro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy and Open Surgery in people with Chronic Calculous Cholecystitis, run by Ministry of Health, Montenegro at 1 site in Montenegro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Montenegro. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine biohumoral and endocrine parameters of response to trauma (time frame: first 24h after the surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077115, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.