Gallbladder DiseasePhase 2NCT00961506
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
A Phase 2 study testing LESS cholecystectomy and Laparoscopic cholecystectomy in people with Gallbladder Disease, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Disease
- What is being tested?
- LESS cholecystectomy and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to Aug 2009
- Phase
- Phase 2
- 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
- gallbladder disease Age: 18-99
Who cannot join
- intolerance to laparoscopy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Geneva
Geneva, Canton of Geneva, 1211
About this study
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.
- Conditions
- Gallbladder Disease
- Being tested
- LESS cholecystectomy, Laparoscopic cholecystectomy
- Keywords
- cholecystectomy, gallbladder, laparoscopy, laparoendoscopic
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LESS cholecystectomyProcedure or surgery
LESS cholecystectomy
Laparoscopic cholecystectomyProcedure or surgery
laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| LESS cholecystectomy | Experimental | LESS cholecystectomy Receives: Procedure: LESS cholecystectomy |
| Laparoscopic cholecystectomy | Active comparator | Laparoscopic cholecystectomy Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body image scale
Measured: 1 months
Secondary outcomes (4)
pain VAS
Measured: 10 days
Analgesic requirement
time to return to work
scar scale
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Pascal Bucher, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961506
- Sponsor's protocol ID
- CER-08-145a
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2009
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00961506
- Acronym / sponsor ID
- CER-08-145a
- Conditions
- Gallbladder Disease
- Keywords
- cholecystectomy, gallbladder, laparoscopy, laparoendoscopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Aug 2009 (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.
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LESS cholecystectomy | Experimental | Procedure: LESS cholecystectomyLESS cholecystectomy |
| Laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyLaparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gallbladder disease Age: 18-99
Key exclusion criteria (1 listed)
- intolerance to laparoscopy
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 |
|---|---|---|
| LESS cholecystectomyLESS cholecystectomy | Procedure or surgery | LESS cholecystectomy |
| Laparoscopic cholecystectomylaparoscopic cholecystectomy | Procedure or surgery | Laparoscopic cholecystectomy |
Primary outcome
Body image scale
Time frame: 1 months
4 secondary outcomes
pain VAS
Time frame: 10 days
Analgesic requirement
time to return to work
scar scale
Time frame: 1 months
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 19 Aug 2009.
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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.
Pascal Bucher, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LESS cholecystectomy and Laparoscopic cholecystectomy in people with Gallbladder Disease, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 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 19 Aug 2009. 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 Switzerland. 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 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.
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?
Body image scale (time frame: 1 months). 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 19 Aug 2009.