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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
  Purpose

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.


Condition Intervention
Postoperative Complications Operative Time Surgical Volume Procedure: laparoscopic gastric bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Structured Bariatric Fellowship Programme Moelholm Private Hospital - Denmark. Learning Laparoscopic RY - Gastric Bypass One Way to do it

Further study details as provided by Private Hospital Moelholm:

Primary Outcome Measures:
  • complication rate
    data of all postoperative complications untill 4 months post OP were collected


Enrollment: 300
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
gastric bypass patients
Consecutive series of 300 patients undergoing laparoscopic gastric bypass
Procedure: laparoscopic gastric bypass
laparoscopic gastric bypass

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 consequtive patients already sceduled for laparoscopic gastric bypass surgery
Criteria

Inclusion Criteria:

patients undergoing laparoscopic gastric bypass

Exclusion Criteria:

  • super obesity
  • male patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257789


Locations
Denmark
Private Hospital Moelholm
Vejle, Denmark, 8900
Sponsors and Collaborators
Private Hospital Moelholm
  More Information

Responsible Party: Thorbjorn Sommer, Private Hospital Moelholm
ClinicalTrials.gov Identifier: NCT01257789     History of Changes
Other Study ID Numbers: PHM-GB learning study
First Submitted: December 9, 2010
First Posted: December 10, 2010
Last Update Posted: December 10, 2010
Last Verified: February 2010

Keywords provided by Private Hospital Moelholm:
laparoscopic gastric bypass
learning curve
complications
operative time

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes