Postoperative ComplicationsNCT01257789
Eliminating Learning Curve Related Morbidity in Fast Track Laparoscopic Roux-en-Y Gastric Bypass
An observational study of Postoperative Complications and Operative Time, run by Private Hospital Moelholm at 1 site in Denmark.
Trial summary
Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant learning curve. We report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track LRYGB. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Complications, Operative Time, Surgical Volume
- What is being tested?
- laparoscopic gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Feb 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 300 consequtive patients already sceduled for laparoscopic gastric bypass surgery
Who may be able to join
- patients undergoing laparoscopic gastric bypass
Who cannot join
- super obesity
- male patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structured Bariatric Fellowship Programme Moelholm Private Hospital - Denmark. Learning Laparoscopic RY - Gastric Bypass One Way to do it
Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant learning curve. We report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track LRYGB.
Method: Using a stepwise training programme the RY gastric bypass operation was divided into an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic surgeon without experience in upper GI surgery was mentored by an experienced bariatric surgeon. During 6 months full time fellowship 300 operations were performed.
Read more
Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which the mentor surgeon did the other part of the operation. In 110 patients the trainee performed both procedures. Two percent had peri-operative complications compared to 1% of 1000 patients. All were repaired and had an uneventful recovery. Two percent had postoperative complications < 30 days compared to 2.8% in the clinic. In the trainees series there were no leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic. Concerning time to discharge there was no difference between patients operated by the trainee and the standard of the clinic.
Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery eliminates morbidity of the learning curve without affecting the volume.
- Conditions
- Postoperative Complications, Operative Time, Surgical Volume
- Being tested
- laparoscopic gastric bypass
- Keywords
- laparoscopic gastric bypass, learning curve, complications, operative time
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gastric bypassProcedure or surgery
laparoscopic gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| gastric bypass patients | Consecutive series of 300 patients undergoing laparoscopic gastric bypass Receives: Procedure: laparoscopic gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
data of all postoperative complications untill 4 months post OP were collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Private Hospital Moelholm
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257789
- Sponsor's protocol ID
- PHM-GB learning study
- Status last verified
- Feb 2010
- First submitted
- 9 Dec 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
- Structured Bariatric Fellowship Programme Moelholm Private Hospital - Denmark. Learning Laparoscopic RY - Gastric Bypass One Way to do it
- ClinicalTrials.gov ID
- NCT01257789
- Acronym / sponsor ID
- PHM-GB learning study
- Conditions
- Postoperative Complications, Operative Time, Surgical Volume
- Keywords
- laparoscopic gastric bypass, learning curve, complications, operative time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Private Hospital MoelholmUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Dec 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.
Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant learning curve. We report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track LRYGB.
Method: Using a stepwise training programme the RY gastric bypass operation was divided into an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic surgeon without experience in upper GI surgery was mentored by an experienced bariatric surgeon. During 6 months full time fellowship 300 operations were performed.
Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which the mentor surgeon did the other part of the operation. In 110 patients the trainee performed both procedures. Two percent had peri-operative complications compared to 1% of 1000 patients. All were repaired and had an uneventful recovery. Two percent had postoperative complications < 30 days compared to 2.8% in the clinic. In the trainees series there were no leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic. Concerning time to discharge there was no difference between patients operated by the trainee and the standard of the clinic.
Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery eliminates morbidity of the learning curve without affecting the volume.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric bypass patients | – | Procedure: laparoscopic gastric bypassConsecutive series of 300 patients undergoing laparoscopic gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 consequtive patients already sceduled for laparoscopic gastric bypass surgery
Key inclusion criteria (1 listed)
- patients undergoing laparoscopic gastric bypass
Key exclusion criteria (2 listed)
- super obesity
- male patients
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 gastric bypasslaparoscopic gastric bypass | Procedure or surgery | gastric bypass patients |
Primary outcome
complication rate
data of all postoperative complications untill 4 months post OP were collected
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.
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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?
An observational study of Postoperative Complications and Operative Time, run by Private Hospital Moelholm at 1 site in Denmark.
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 2 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 Denmark. 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?
complication rate. 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.