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临床试验/NCT03526783
NCT03526783已完成不适用

A Comparison of the Mini/One Anastomosis-Gastric Bypass and Roux-en-Y Gastric Bypass for Conversion of Failed Sleeve Gastrectomy

Sana Klinikum Offenbach2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
2
主要终点
Weight Loss

研究概览

简要总结

Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease.

This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.

详细描述

All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra- and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year follow-up.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with failed sleeve due to
  • weight regain
  • weight loss failure
  • gastro-esophageal reflux disease Grade B

排除标准

  • 未提供

研究组 & 干预措施

Failed sleeve gastrectomy - RNYGB

Other

Intervention: Roux en Y gasric bypass (RNYGB)

干预措施: Roux en Y gastric bypass (Procedure)

Failed sleeve gastrectomy - MGB/OAGB

Other

Inervention: Mini/One anastomosis gasic bypass (MGB/OAGB)

干预措施: Mini/One anastomosis gastric bypass (Procedure)

结局指标

主要结局

Weight Loss

时间窗: 1 year follow-up

Total Body Weight Loss in %

次要结局

  • Perioperative Complications(up to 30 days postsurgery)
  • Postoperative Morbidity(1 year follow-up)

研究者

发起方
Sana Klinikum Offenbach
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonja Chiappetta, MD

MD, Senior Consultant, Principal Investigator

Sana Klinikum Offenbach

研究点 (2)

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