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临床试验/NCT02658955
NCT02658955已完成不适用

Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital

Hospital del Mar1 个研究点 分布在 1 个国家目标入组 1,164 人开始时间: 2016年6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
入组人数
1,164
试验地点
1
主要终点
Incisional hernia and burst abdomen rate

研究概览

简要总结

Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

详细描述

Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique.

Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with "short stitch" technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients operated on by laparotomy

排除标准

  • •Previous mesh
  • •Concomitant hernia repair

研究组 & 干预措施

Short stitch

Experimental

Patients in which abdominal wall is closed by short stitch technique

干预措施: Short stitch (Procedure)

Large stitch

No Intervention

Patients who didn't receive properly closure according with the protocol

结局指标

主要结局

Incisional hernia and burst abdomen rate

时间窗: One year

Analysis of the number of incisional hernia and burst abdomen after one year follow-up

次要结局

  • Rate of fulfillment of the protocol(One year)
  • Mesh complications rate(One year)
  • Complication rate(One month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José A. Pereira

MD

Hospital del Mar

研究点 (1)

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