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临床试验/NCT04394338
NCT04394338已完成不适用

The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair

Mahidol University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2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
60
试验地点
2
主要终点
Duration

研究概览

简要总结

Inguinal hernia is one of the most-common surgical conditions. Incidence is about 27% in males and 3% in females.The treatment of this condition is inguinal hernia repair operation which can be approached with several techniques; open hernia repair, laparoscopic hernia repair and robotic hernia repair. The current guidelines recommend the hernia repair operation with mesh placement either Lichtenstenstein operation or laparoscopic technique; transabdominal preperitoneal technique (TAPP) and totally extraperitoneal technique (TEP). In the laparoscopic approach, one of the complications that can occur is post-operative pain from the mesh fixator. So the self-gripping mesh becomes another option to decrease this incidence.However the adhesive property of the mesh is still challenging for many surgeons. Several techniques of self-gripping mesh placement were introduced. One of the popular techniques is bilateral vertical folding of self-gripping mesh which still causes some adhesive problems when introduced to the target area. This research's aim is to present a new technique of the self-gripping mesh placement which is more effective, more convenient, and decreases the time taken to place the mesh at the surgery site.

详细描述

A randomized control trail comparing the duration of mesh placement and surgeon satisfaction of self-gripping mesh with plastic sheath and with non-plastic sheath covering mesh. Patients with groin hernia who planned for elective laparoscopically repair hernia with self-gripping mesh at Ramathibodi Hospital, Faculty of Medicine, Mahidol University will are informed of the details of research at the outpatient department before admission. 1:1 open label randomization trail was designed dividing the patients into two groups by the study number. The operation will be done with the standard laparoscopic hernia repair technique by experienced surgeons.

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
Single (Participant)

入排标准

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

入选标准

  • Elective laparoscopic inguinal hernia repair

排除标准

  • Rejected or withdrawn consent

研究组 & 干预措施

plastic sheath covering

Active Comparator

plastic sheath was prepared with the standard 9 cmx15cm self-gripping mesh. Then the meshe were folded and unfolded over or under the plastic sheaths in different directions.

干预措施: self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia (Other)

mesh placement without plastic sheath

No Intervention

self-gripping mesh were placed without plastic sheath.

结局指标

主要结局

Duration

时间窗: 5 min

the duration of self-gripping mesh placement with plastic sheath

Mesh placement time

时间窗: During the surgical procedure

The duration from the introduction of the self-gripping mesh into the preperitoneal space until the completion of its final placement.

次要结局

  • wound infection(30 days)
  • post operative pain: pain scores(24 hours after surgery)
  • wound infection(30 days post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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