跳至主要内容
临床试验/NCT03438786
NCT03438786Unknown不适用

Trans-inguinal Pre-peritoneal (TIPP) Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair

Assiut University0 个研究点目标入组 30 人开始时间: 2018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
入组人数
30
主要终点
comparison between the 2 techniques regarding presence and duration of post-operative chronic pain

研究概览

简要总结

Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. Recurrence of inguinal hernia was initially a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been reported as low as 1-4%[2], a drop from up to 10%. But increased incidence of chronic groin pain following LR.

Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position .

Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. So aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty

详细描述

This study is a prospective randomized study including all Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH during the period from 3- 2018 to 6- 2020

Methodology:

Patients will be classified into two groups according to the surgical procedure performed as follows:

  • Group A: Patients undergoing TIPP hernioplasty
  • Group B: Patients undergoing lichtnestein's technique hernioplasty

Sample size:15 patients for each group.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •. Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH

排除标准

  • •Patients who were unfit for operation.
  • •Patients with bilateral or recurrent inguinal hernia
  • •Patients aged below 18 years,
  • •Patients undergoing emergency hernia repairs

研究组 & 干预措施

group A

Experimental

Patients undergoing trans-inguinal pre-peritoneal (TIPP) hernioplasty

干预措施: Trans-inguinal Pre-peritoneal Hernioplasty (Procedure)

group B

Experimental

Patients undergoing lichtnestein's hernioplasty

干预措施: Lichtnestein's hernioplasty (Procedure)

结局指标

主要结局

comparison between the 2 techniques regarding presence and duration of post-operative chronic pain

时间窗: visits will be within 6 months post operative

post operative clinical examination for assessment of the presence and duration of chronic pain

次要结局

  • operation time(intra-operative)
  • Duration of hospital stay post operative(first week post operative)
  • presence of any wound complication by examining the wound(first 2 weeks post operative)
  • recurrence rate(6 to 12 month post operative)
  • time needed for the patient to return to work(1 month post operative)

研究者

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

Mohamad Hamdy

Resident doctor at General surgery department

Assiut University

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