Clinical Trials Directory

Trials / Completed

CompletedNCT01257789

Eliminating Learning Curve Related Morbidity in Fast Track Laparoscopic Roux-en-Y Gastric Bypass

Structured Bariatric Fellowship Programme Moelholm Private Hospital - Denmark. Learning Laparoscopic RY - Gastric Bypass One Way to do it

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
Private Hospital Moelholm · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
PROCEDURElaparoscopic gastric bypasslaparoscopic gastric bypass

Timeline

Start date
2009-03-01
Primary completion
2009-09-01
Completion
2010-02-01
First posted
2010-12-10
Last updated
2010-12-10

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01257789. Inclusion in this directory is not an endorsement.