跳至主要内容
临床试验/NCT01257789
NCT01257789已完成不适用

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

Private Hospital Moelholm1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
complication rate

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients undergoing laparoscopic gastric bypass

排除标准

  • super obesity
  • male patients

结局指标

主要结局

complication rate

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

次要结局

未报告次要终点

研究者

发起方
Private Hospital Moelholm
申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Eliminating Learning Curve Related Morbidity in Fast... | 临床试验