Gallstone DiseaseNCT01873638
Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
A study testing Cholecystectomy in people with Gallstone Disease, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gallstone Disease
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2006to Apr 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cholelithiasis confirmed by preoperative ulrasound
- No significant co-morbidities
- The ASA physical status classification 1 or 2
- Age 18 to 65 yrs.
- BMI less than 35
- Less than a one hour journey from hospital to home
- Patient´s own motivation to daysurgery
Who cannot join
- Elevated liver laboratory tests
- Earlier jaundice
- A suspicion or verified stones in the common bile duct
- Acute cholecystitis
- A history of pancreatitis
- Hepatic cirrhosis
Show all 11Show fewer
- Suspicion of cancer
- Previous open upper abdominal surgery
- Asthma
- Peptic ulcer
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.
- Conditions
- Gallstone Disease
- Being tested
- Cholecystectomy
- Keywords
- 5-year outcome after cholecystectomy
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Minilaparotomy | Other | Minilaparotomy cholecystectomy as a day surgery Receives: Procedure: Cholecystectomy |
| Laparoscopy | Other | Laparoscopic cholecystectomy as a day surgery Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-surgical pain
Measured: Five year outcome
Secondary outcomes (1)
Quality of life
Measured: Five year outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startFeb 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matti Eskelinen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873638
- Sponsor's protocol ID
- KUH5200630
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 10 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
- ClinicalTrials.gov ID
- NCT01873638
- Acronym / sponsor ID
- KUH5200630
- Conditions
- Gallstone Disease
- Keywords
- 5-year outcome after cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Jun 2013 (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.
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minilaparotomy | Other | Procedure: CholecystectomyMinilaparotomy cholecystectomy as a day surgery |
| Laparoscopy | Other | Procedure: CholecystectomyLaparoscopic cholecystectomy as a day surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cholelithiasis confirmed by preoperative ulrasound
- No significant co-morbidities
- The ASA physical status classification 1 or 2
- Age 18 to 65 yrs.
- BMI less than 35
Key exclusion criteria (11 listed)
- Elevated liver laboratory tests
- Earlier jaundice
- A suspicion or verified stones in the common bile duct
- Acute cholecystitis
- A history of pancreatitis
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 |
|---|---|---|
| Cholecystectomy | Procedure or surgery | Laparoscopy, Minilaparotomy |
Primary outcome
Chronic post-surgical pain
Time frame: Five year outcome
1 secondary outcome
Quality of life
Time frame: Five year outcome
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 10 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy in people with Gallstone Disease, run by Kuopio University Hospital at 1 site in Finland.
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 7 inclusion and 11 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 10 Jun 2013. 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 Finland. 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?
Chronic post-surgical pain (time frame: Five year outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2013.