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临床试验/NCT06643234
NCT06643234尚未招募不适用

Sublay Versus Intraperitoneal Onlay Mesh Repair in Large Ventral Hernias. A New Technique

Ahmed Kahlawy Mahrous Mohamed0 个研究点目标入组 50 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
-Recurrence rate one year post operative.

研究概览

简要总结

The aims of this study is to compare the efficacy of modified sublay hernioplasty versus intraperitoneal onlay mesh repair for large ventral hernias.

Specifically, this study will assess the primary outcome of recurrence rate one year post surgery and evaluate secondary outcomes, including intraoperative complications, infection rates, pain levels, and post operative hospital stay durations.

详细描述

In general surgery, the management of ventral abdominal hernias characterized by the protrusion of tissue through weaknesses in the abdominal wall presents significant challenges, particularly when dealing with large ventral hernias, defined as those ≥10 cm or those under tension if closed primarily.

Incisional hernias, a specific subset of ventral hernias, add to the complexity of repair.

While the Intraperitoneal Onlay Mesh (IPOM) technique is noted for its reduced surgical and postoperative complications and lower reoperation rates, it also suffers from high costs, limited availability of specialized meshes like dynamesh, and increased intraoperative complications.

Alternatively, the modified open sublay technique, which employs a primary retro-muscular fascial repair and uses an affordable polypropylene mesh, offers a promising and cost effective solution with potential for a tension free repair.

This thesis aims to evaluate and compare these techniques to identify the most effective approach for large ventral hernia repair, balancing surgical outcomes, and complication rates.

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

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age (18-70) years, both sexes.
  • Fitness for surgery.
  • Patients with uncomplicated ventral hernia.
  • Large anterior abdominal wall defect.

排除标准

  • Patients don't fit for general anesthesia due to sever co-morbidity.
  • Patients with complicated ventral hernia.
  • Patient refusal of surgical intervention.
  • History of bleeding disorders.
  • Pregnancy in female patients

结局指标

主要结局

-Recurrence rate one year post operative.

时间窗: 1 year postoperative

Number of recurrent cases

次要结局

  • 1-infection rates(number of cases) 2-pain level( according to Visual Analog Score for pain) 3-post operative hospital stay duration(number of days) 4-intra and post operative complications(as iatrogenic injury and adhesions).(1 year postoperative)

研究者

发起方
Ahmed Kahlawy Mahrous Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Kahlawy Mahrous Mohamed

Principal investigator

Assiut University

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