CTRI/2025/04/084321尚未招募Phase 3 4
To compare self-fixating polypropylene mesh versus 3D anatomical polypropylene mesh in laparoscopic trans abdominal preperitoneal hernioplasty: A Randomized Controlled trial
Aiims New Delhi1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年4月21日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Post operative pain at 20-24 hrs following surgery in terms of Visual analogue scale (VAS).
研究概览
简要总结
Inguinal hernia is one of the most common problems in the surgical patients. Various types of meshes are used for the repair of inguinal hernia. In this study, the use of 3D anatomical mesh with tacker fixation, provide structural support but may lead to issues related to mesh fixation. Self-grip mesh, by adhering directly to tissue without tackers, offers a potentially beneficial alternative like less post operative pain. We propose this randomised trial to compare self-fixating mesh and 3D anatomical mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with unilateral inguinal hernia planned for elective transabdominal preperitoneal hernioplasty.
排除标准
- •Irreducible hernia Intra-operative diagnosis of B/L inguinal hernia History of lower abdominal surgery Chronic groin pain Chronic analgesics abuser Any concomitant procedure planned.
结局指标
主要结局
Post operative pain at 20-24 hrs following surgery in terms of Visual analogue scale (VAS).
时间窗: 20-24 hrs following surgery
次要结局
- Mesh deployment time
- Surgeons satisfaction score(intraoperative)
- chronic pain and recurrence(3 months)
- Quality of life of the patients(3 months)
研究者
DR Jarapala Venu Madhav
AIIMS NEW DELHI
研究点 (1)
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