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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01257789
First Posted: December 10, 2010
Last Update Posted: December 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Private Hospital Moelholm
December 9, 2010
December 10, 2010
December 10, 2010
March 2009
September 2009   (Final data collection date for primary outcome measure)
complication rate
data of all postoperative complications untill 4 months post OP were collected
Same as current
No Changes Posted
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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

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
300 consequtive patients already sceduled for laparoscopic gastric bypass surgery
  • Postoperative Complications
  • Operative Time
  • Surgical Volume
Procedure: laparoscopic gastric bypass
laparoscopic gastric bypass
gastric bypass patients
Consecutive series of 300 patients undergoing laparoscopic gastric bypass
Intervention: Procedure: laparoscopic gastric bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2010
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

patients undergoing laparoscopic gastric bypass

Exclusion Criteria:

  • super obesity
  • male patients
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01257789
PHM-GB learning study
No
Not Provided
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Thorbjorn Sommer, Private Hospital Moelholm
Private Hospital Moelholm
Not Provided
Not Provided
Private Hospital Moelholm
February 2010