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临床试验/NCT06255314
NCT06255314尚未招募不适用

Evaluation of Minimally Invasive Ventral Hernioplasty With Extraperitoneal Mesh Placement

Assiut University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
2
主要终点
Operative time

研究概览

简要总结

  1. Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications.
  2. Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties

详细描述

The laparoscopic ventral hernia repair was first introduced by LeBlanc and Booth in the early 1990s . Since its introduction, it has continued to evolve and has become an important option in the hernia surgeon's armamentarium. However, only 27.4% of ventral hernia repairs are performed laparoscopically, likely because of the relatively advanced nature of this procedure and because all hernias may not be suitable for a laparoscopic approach. Using current techniques, numerous studies have documented the safety and efficacy of this approach. Some data suggest that the laparoscopic approach results in a shorter hospital stay and lower recurrence rates compared with open approaches. However, pain may still be significant after laparoscopic repairs and there are not significant advantages from this standpoint. Nonetheless, it is well accepted that the primary advantage of the laparoscopic approach is that wound infections are less frequent compared with open approaches .LeBlanc and Booth in 1993 first reported application of intra-peritoneal onlay mesh (IPOM) for ventral and incisional hernia, However the technique requires expensive fixation devices which may cause acute and chronic pain .The laparoscopic groin hernia repair using synthetic mesh in TEP or TAPP are acceptable surgical techniques today These techniques are rarely associated with mesh induced complications, the reason being extraperitoneal placement of synthetic mesh. It is apparent that despite great progress in mesh technology, nearly all types of meshes have been found to produce a varying level of adhesion or tissue reaction, regardless of the material and coating used. Preoperatively unpredictable, a mesh-induced visceral complication may occur in some patients to produce severe reaction or major mesh-related adverse events.The incitation to develop certain novel minimally invasive techniques that enables researchers to bring the mesh out of abdominal cavity has been an exciting trend in laparoscopic hernia repair.

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

入选标准

  • • Able to give informed consent for inclusion in the study
  • Age of the patient : above 18 years
  • Any type of ventral hernia including umbilical,paraumbilical,epigastric,spigelian and incisional hernias

排除标准

  • • Patients with inguinal hernia.
  • Strangulated or obstructed hernia.
  • Previous mesh hernia repair.
  • Loss of abdominal domain.
  • Infected or contaminated field.
  • Defect size more than 10cm.

结局指标

主要结局

Operative time

时间窗: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair.

Intra operative injuries including bowel or vascular injuries

时间窗: intra operative

次要结局

  • • Surgical site occurrence of hematoma ,seroma, necrosis(: 30 days)
  • • Surgical site infection(postoperative up to 1month)
  • • Hernia recurrence(: 1year)
  • Cost effectiveness(: 6months)
  • •Rate of mesh related complication such as bowel erosion(1 year)

研究者

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

Mohamed Ashraf Mohamed Badr

teaching assistant

Assiut University

研究点 (2)

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