Biliary Tract DiseasesPhase 2/3NCT00370344
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
A Phase 2/3 study testing Laparoscopic cholecystectomy and Small-incision open cholecystectomy in people with Biliary Tract Diseases and Gallbladder Diseases, run by Umeå University at 2 sites in Sweden.
Trial summary
The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Diseases, Gallbladder Diseases, Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy and Small-incision open cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2006to Nov 2011
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cholecystectomy is considered the best available treatment.
- The patient understands trial information and is capable of making a decision after having received information.
- The patient wants to undergo cholecystectomy and accepts participation in the trial.
Who cannot join
- Age below 18 years.
- The patient is unable to understand trial information.
- Competence for both trial groups are lacking when a patient is randomized.
- The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
- The indication of cholecystectomy is proven or suspected cancer of the gallbladder.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Lycksele Hospital
Lycksele, Västerbotten County
Department of Surgery and Perioperative Sciences, Umeå University Hospital
Umeå, Västerbotten County, SE 90185
About this study
Official title: An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.
Read the detailed description
Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. However, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.
Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.
- Being tested
- Laparoscopic cholecystectomy, Small-incision open cholecystectomy
- Keywords
- Gallbladder diseases, gallstones, cholecystectomy, minilaparotomy, laparoscopy
- Medical subject headings
- Biliary Tract Diseases, Gallbladder Diseases, Cholecystitis, Cholecystolithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.
Small-incision open cholecystectomyProcedure or surgery
Operation by experts in small-incision open cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy | Active comparator | Operation by experts in laparoscopy. Receives: Procedure: Laparoscopic cholecystectomy |
| Small-incision open cholecystectomy | Active comparator | Operation by experts in small-incision cholecystectomy. Receives: Procedure: Small-incision open cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life, postoperative pain, and health care costs.
Measured: Three, seven, eleven, and 30 postoperative days and one year after the operation.
Secondary outcomes (1)
Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.
Measured: Thirty days and one year after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract DiseasesStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Norrlandstingens Regionförbund
- Responsible party
- Sponsor
- Investigators
- Markku M Haapamäki, MD, PhD, Principal investigator, Umeå UniversityMats Rosenmüller, MD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370344
- Sponsor's protocol ID
- GANO-05-147M
- Status last verified
- Apr 2015
- First submitted
- 30 Aug 2006
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. doi: 10.1136/bmj.330.7482.88.
PubMed 15637373Harju J, Juvonen P, Eskelinen M, Miettinen P, Paakkonen M. Minilaparotomy cholecystectomy versus laparoscopic cholecystectomy: a randomized study with special reference to obesity. Surg Endosc. 2006 Apr;20(4):583-6. doi: 10.1007/s00464-004-2280-6. Epub 2006 Jan 25.
PubMed 16437283Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006231. doi: 10.1002/14651858.CD006231.
PubMed 17054285Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006229. doi: 10.1002/14651858.CD006229.
PubMed 17054284Rosenmuller MH, Nilsson E, Lindberg F, Aberg SO, Haapamaki MM. Costs and quality of life of small-incision open cholecystectomy and laparoscopic cholecystectomy - an expertise-based randomised controlled trial. BMC Gastroenterol. 2017 Apr 8;17(1):48. doi: 10.1186/s12876-017-0601-1.
PubMed 28388942Rosenmuller MH, Thoren Ornberg M, Myrnas T, Lundberg O, Nilsson E, Haapamaki MM. Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy. Br J Surg. 2013 Jun;100(7):886-94. doi: 10.1002/bjs.9133.
PubMed 23640665
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00370344
- Acronym / sponsor ID
- GANO-05-147M
- Keywords
- Gallbladder diseases, gallstones, cholecystectomy, minilaparotomy, laparoscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Norrlandstingens Regionförbund
- Study start
- Sep 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Aug 2006 (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 trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.
Detailed description
Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. However, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.
Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyOperation by experts in laparoscopy. |
| Small-incision open cholecystectomy | Active comparator | Procedure: Small-incision open cholecystectomyOperation by experts in small-incision cholecystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cholecystectomy is considered the best available treatment.
- The patient understands trial information and is capable of making a decision after having received information.
- The patient wants to undergo cholecystectomy and accepts participation in the trial.
Key exclusion criteria (5 listed)
- Age below 18 years.
- The patient is unable to understand trial information.
- Competence for both trial groups are lacking when a patient is randomized.
- The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
- The indication of cholecystectomy is proven or suspected cancer of the gallbladder.
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 cholecystectomyOperation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation. | Procedure or surgery | Laparoscopic cholecystectomy |
| Small-incision open cholecystectomyOperation by experts in small-incision open cholecystectomy. | Procedure or surgery | Small-incision open cholecystectomy |
Primary outcome
Health-related quality of life, postoperative pain, and health care costs.
Time frame: Three, seven, eleven, and 30 postoperative days and one year after the operation.
1 secondary outcome
Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.
Time frame: Thirty days and one year after the operation.
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 24 Apr 2015.
- Background: PubMed 15637373Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. doi: 10.1136/bmj.330.7482.88.
- Background: PubMed 16437283Harju J, Juvonen P, Eskelinen M, Miettinen P, Paakkonen M. Minilaparotomy cholecystectomy versus laparoscopic cholecystectomy: a randomized study with special reference to obesity. Surg Endosc. 2006 Apr;20(4):583-6. doi: 10.1007/s00464-004-2280-6. Epub 2006 Jan 25.
- Background: PubMed 17054285Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006231. doi: 10.1002/14651858.CD006231.
- Background: PubMed 17054284Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006229. doi: 10.1002/14651858.CD006229.
- Derived from this study: PubMed 28388942Rosenmuller MH, Nilsson E, Lindberg F, Aberg SO, Haapamaki MM. Costs and quality of life of small-incision open cholecystectomy and laparoscopic cholecystectomy - an expertise-based randomised controlled trial. BMC Gastroenterol. 2017 Apr 8;17(1):48. doi: 10.1186/s12876-017-0601-1.
- Derived from this study: PubMed 23640665Rosenmuller MH, Thoren Ornberg M, Myrnas T, Lundberg O, Nilsson E, Haapamaki MM. Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy. Br J Surg. 2013 Jun;100(7):886-94. doi: 10.1002/bjs.9133.
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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.
Markku M Haapamäki, MD, PhD principal investigator
Umeå University
Mats Rosenmüller, MD principal investigator
Umeå University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Laparoscopic cholecystectomy and Small-incision open cholecystectomy in people with Biliary Tract Diseases and Gallbladder Diseases, run by Umeå University at 2 sites in Sweden.
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 3 inclusion and 5 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Health-related quality of life, postoperative pain, and health care costs. (time frame: Three, seven, eleven, and 30 postoperative days and one year after the operation.). 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 NCT00370344, which also lists 6 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 24 Apr 2015.