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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257789
• Other study ID #: PHM-GB learning study
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: December 9, 2010
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Private Hospital Moelholm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Board of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

patients undergoing laparoscopic gastric bypass

Exclusion Criteria:

• super obesity

• male patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Operative Time
• Postoperative Complications
• Surgical Volume

Intervention

Procedure:
• laparoscopic gastric bypass
laparoscopic gastric bypass

Locations

Country	Name	City	State
Denmark	Private Hospital Moelholm	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Private Hospital Moelholm

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication rate	data of all postoperative complications untill 4 months post OP were collected		Yes