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临床试验/NCT05661097
NCT05661097招募中不适用

Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair

Bo Li1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3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
招募中
发起方
入组人数
100
试验地点
1
主要终点
recrudescence

研究概览

简要总结

By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under laparoscopy and provide evidence based medicine. with In the research process of the research group, a database on abdominal wall hernia will be established for the future Further study of hernia has laid a solid foundation.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Conform to the diagnostic criteria of abdominal wall hernia;
  • •Patients with general physical condition and can tolerate general anesthesia and laparoscopic surgery; ③ After explaining the situation to the patients and their families, they agreed to join the research group.

排除标准

  • •The diagnostic criteria of abdominal wall hernia were not met; ② Patients who have serious medical diseases and cannot tolerate laparoscopic surgery; ③ Patients with mental illness; ④ The judgment is affected by incomplete data.

研究组 & 干预措施

Small hernia ring group with continuous suture

Active Comparator

Continuous suture of hernia ring with barbed wire<3cm

干预措施: Suture mode (Procedure)

Small hernia ring group with discontinuous full-thickness suture

Active Comparator

Intermittent full layer suture to close hernia rings<3cm

干预措施: Suture mode (Procedure)

Large hernia ring group with continuous suture

Active Comparator

Continuous suture of hernia ring with barbed wire>3cm

干预措施: Suture mode (Procedure)

Large hernia ring group with discontinuous full-thickness suture

Active Comparator

Intermittent full layer suture to close hernia rings>3cm

干预措施: Suture mode (Procedure)

Large hernia ring group with continuous suture and discontinuous full-thickness suture

Experimental

Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings>3cm

干预措施: Suture mode (Procedure)

结局指标

主要结局

recrudescence

时间窗: 24 months after operation

Whether abdominal wall hernia recurred within 24 months

次要结局

  • Bleeding volume(during operation)
  • Seroma(immediately after the surgery)
  • Infected(immediately after the surgery)
  • Time to close the hernia ring(during operation)
  • Pain level(immediately after the surgery)
  • Gastrointestinal recovery time(immediately after the surgery)

研究者

发起方
Bo Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bo Li

Chief physician

Qianfoshan Hospital

研究点 (1)

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