Symptomatic Gallbladder StonesPhase 2/3NCT00904865
Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
A Phase 2/3 study testing SPA cholecystectomy and Laparoscopic cholecystectomy in people with Symptomatic Gallbladder Stones and Cholecystitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Background: Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Gallbladder Stones, Cholecystitis, Biliary Pancreatitis
- What is being tested?
- SPA cholecystectomy and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Feb 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
- Age more than 18 years
Who cannot join
- Contraindication to laparoscopy
- Liver disease
- Cognitive trouble
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Geneva
Geneva, Canton of Geneva, 1211
Pascal Bucher, MD, ¦41223723311 ext. 7958420, pascal.bucher@hcuge.ch
Pascal Bucher, MD
About this study
Official title: Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
Background:
Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.
Read more
Objective:
Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.
Hypothesis:
SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.
Methods:
All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.
Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.
Randomization will be performed before surgeries after patients have given their informed consent to the study.
No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.
Endpoints:
- Morbidity
- Body image and Cosmetic results
- Post-operative pain (opioid sparing effect)
- Operative time
- Hospital stay
- Being tested
- SPA cholecystectomy, Laparoscopic cholecystectomy
- Keywords
- Single port access, Laparoscopy, cholecystectomy, cholangiography, cosmesis
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPA cholecystectomyProcedure or surgery
SPA cholecystectomy
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | SPA cholecystectomy Receives: Procedure: SPA cholecystectomy |
| 2 | Other | laparoscopic cholecystectomy Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmesis, body image and quality of life scale
Measured: at 1 month
Secondary outcomes (3)
Post-operative morbidity
Measured: at 30 days
Post-operative pain
Measured: 10 days
Operative time
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Gallbladder StonesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- NCT00904865
- Sponsor's protocol ID
- CER-08-145
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 20 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bucher P, Pugin F, Buchs N, Ostermann S, Charara F, Morel P. Single port access laparoscopic cholecystectomy (with video). World J Surg. 2009 May;33(5):1015-9. doi: 10.1007/s00268-008-9874-4.
PubMed 19116734Bucher P, Pugin F, Buchs NC, Ostermann S, Morel P. Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg. 2011 Dec;98(12):1695-702. doi: 10.1002/bjs.7689. Epub 2011 Sep 30.
PubMed 21964736Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
PubMed 21910897
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
- ClinicalTrials.gov ID
- NCT00904865
- Acronym / sponsor ID
- CER-08-145
- Keywords
- Single port access, Laparoscopy, cholecystectomy, cholangiography, cosmesis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (estimated)
- First posted
- 20 May 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.
Background:
Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.
Objective:
Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.
Hypothesis:
SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.
Methods:
All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.
Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.
Randomization will be performed before surgeries after patients have given their informed consent to the study.
No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.
Endpoints:
- Morbidity
- Body image and Cosmetic results
- Post-operative pain (opioid sparing effect)
- Operative time
- Hospital stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: SPA cholecystectomySPA cholecystectomy |
| 2 | Other | 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)
- Age more than 18 years
Key exclusion criteria (3 listed)
- Contraindication to laparoscopy
- Liver disease
- Cognitive trouble
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 |
|---|---|---|
| SPA cholecystectomySPA cholecystectomy | Procedure or surgery | 1 |
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | 2 |
Primary outcome
Cosmesis, body image and quality of life scale
Time frame: at 1 month
3 secondary outcomes
Post-operative morbidity
Time frame: at 30 days
Post-operative pain
Time frame: 10 days
Operative time
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
- Background: PubMed 19116734Bucher P, Pugin F, Buchs N, Ostermann S, Charara F, Morel P. Single port access laparoscopic cholecystectomy (with video). World J Surg. 2009 May;33(5):1015-9. doi: 10.1007/s00268-008-9874-4.
- Derived from this study: PubMed 21964736Bucher P, Pugin F, Buchs NC, Ostermann S, Morel P. Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg. 2011 Dec;98(12):1695-702. doi: 10.1002/bjs.7689. Epub 2011 Sep 30.
- Derived from this study: PubMed 21910897Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
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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 2/3 study testing SPA cholecystectomy and Laparoscopic cholecystectomy in people with Symptomatic Gallbladder Stones and Cholecystitis, 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 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: status not confirmed, as of the sponsor's last update on 20 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Bucher, MD (+41223723311 ext. 7958420, pascal.bucher@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmesis, body image and quality of life scale (time frame: at 1 month). 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 NCT00904865, which also lists 3 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 20 May 2009.