Given Indication for Gastric Bypass ProcedureNCT01219166
Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study
An observational study of Given Indication for Gastric Bypass Procedure, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Given Indication for Gastric Bypass Procedure
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 437 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2010to Dec 2010
- Phase
- Observational
- 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
Study population: Given indication for laparoscopic Roux-en-Y-gastric bypass
Who may be able to join
- All patients who received a laparoscopic Roux-en-Y-gastric bypass
Who cannot join
- previous CCE
- open gastric bypass procedure
- previous bariatric procedure other than gastric banding
- patients lost to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.
- Being tested
- Laparoscopic Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
Laparoscopic Cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy | Not described | |
| laparoscopic Roux-en-Y-gastric baypass with cholecystectomy | Not described Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
biliary complications resulting from omitted prophylactic cholecystectomy
Measured: 5 years
Secondary outcomes (1)
safety of concurrent cholecystectomy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Given Indication for Gastric Bypass ProcedureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 437 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Investigators
- Martin Thurnheer, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219166
- Sponsor's protocol ID
- EKSG10/140/U
- Status last verified
- Oct 2010
- First submitted
- 12 Oct 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT01219166
- Acronym / sponsor ID
- EKSG10/140/U
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Oct 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.
Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy | – | – |
| laparoscopic Roux-en-Y-gastric baypass with cholecystectomy | – | Procedure: Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given indication for laparoscopic Roux-en-Y-gastric bypass
Key inclusion criteria (1 listed)
- All patients who received a laparoscopic Roux-en-Y-gastric bypass
Key exclusion criteria (4 listed)
- previous CCE
- open gastric bypass procedure
- previous bariatric procedure other than gastric banding
- patients lost to follow up
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 CholecystectomyLaparoscopic Cholecystectomy | Procedure or surgery | laparoscopic Roux-en-Y-gastric baypass with cholecystectomy |
Primary outcome
biliary complications resulting from omitted prophylactic cholecystectomy
Time frame: 5 years
1 secondary outcome
safety of concurrent cholecystectomy
Time frame: 30 days
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 Dec 2010.
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.
Martin Thurnheer, MD principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Given Indication for Gastric Bypass Procedure, run by Cantonal Hospital of St. Gallen 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 4 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 Dec 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 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.
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?
biliary complications resulting from omitted prophylactic cholecystectomy (time frame: 5 years). 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 Dec 2010.