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

NCT01257789 | Completed

• 1 other identifier: PHM-GB learning study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Postoperative Complications; Operative Time; Surgical Volume

Keywords

laparoscopic gastric bypass; learning curve; complications; operative time

Outcome Measures

Primary Outcomes (1)

• complication rate

  data of all postoperative complications untill 4 months post OP were collected

Study Arms (1)

gastric bypass patients

Consecutive series of 300 patients undergoing laparoscopic gastric bypass

Procedure: laparoscopic gastric bypass

Interventions

laparoscopic gastric bypass PROCEDURE

laparoscopic gastric bypass

gastric bypass patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 consequtive patients already sceduled for laparoscopic gastric bypass surgery

You may qualify if:

• patients undergoing laparoscopic gastric bypass

You may not qualify if:

• super obesity
• male patients

Sponsors & Collaborators

• Private Hospital Moelholm: lead

Study Sites (1)

Private Hospital Moelholm

Vejle, 8900, Denmark

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-02

Locations

DK (1)