跳至主要内容
临床试验/CTRI/2023/06/054523
CTRI/2023/06/054523招募中不适用

Light weight mesh vs Ultralight weight mesh in Laparoscopic Inguinal Hernia Repair.

Kodidala Sri Charitha1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年5月7日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
62
试验地点
1
主要终点
To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Postoperative pain (Postoperative day 0,1,2), Chronic groin pain, Seroma formation

研究概览

简要总结

lHernioplasty by prosthetic mesh has become gold standard for repair of Inguinal hernia. Mesh repair has become so important in hernia surgery that some understanding of mesh technology is essential for the modern surgeon. The composition and structure of prosthetic meshes varies widely, which influence in the healing process following meshplasty. The use of synthetic mesh substantially reduce the risk of hernia recurrence.

However, polypropylene meshes have been found to cause chronic inflammatory reactions that persist for years and can have potentially negative effects. These effects include chronic pain and feeling of a foreign body in the groin area, which can influence the patient’s quality of life. It was recorded that the incidence of chronic pain after mesh inguinal hernia happens in about 11 % of patients, and still, 3 % report severe pain 1 year after hernia repair. It has been surmised that the extent of the foreign body reaction with its provoked scar tissue is correlated with the amount of the synthetic material used. This led to the development of so-called lightweight mesh characterized by a reduction in the polypropylene volume, an increase in the pore size, or different web structure.

The light weight mesh (LWM) has larger pore size (3-5mm), low weight per unit area(<50gm/m2), stimulates less inflammatory reaction and provides greater elasticity and more flexibility.

The Ultralight weight mesh (ULWM) has larger pore size , lowest weight per unit (<35gm/m2)

The Aim of this study is to compare Light weight mesh vs Ultralight weight mesh repair outcome in Laparoscopic Inguinal Hernia Repair. The objectives are to qualitatively and quantitatively compare the immediate post-operative and chronic inguinal pain. To assess the two types of meshes in terms of their propensity to have post-operative seroma formation, wound infection. To compare chronic inguinal stiffness/Inguinodynia. To evaluate for incidence of recurrence on follow up.

Inclusion criteria: All adult patients (>18 years) with unilateral /Bilateral groin hernia who underwent elective laparoscopic inguinal hernia repair

Exclusion Criteria: 1. Recurrent inguinal hernia 2. Patients with history of previous surgery in the inguino-scrotal region 3. Patients who underwent any other surgery concurrent with laparoscopic inguinal hernia repair.

Patient will be approached for participating in the study and will be explained the details of this study. Once the patient agrees, informed consent will be taken. The case will then be recruited into the study in either Light weight mesh or Ultralight weight mesh group depending on intra-op decisions made by the treating surgeon. There will be no pre study randomization. We will assess the factors like intra operative complications, post-operative pain on immediate post-operative days(POD) as follows- POD1, POD2. We will also assess postoperative complications, days of hospital stay after surgery and patients will be followed up at the end of 1, 3 and 6 months via telephonic conversation postoperatively for any chronic pain, recurrence.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All adult patients with unilateral /Bilateral groin hernia who underwent elective laparoscopic inguinal hernia repair.

排除标准

  • Recurrent inguinal hernia
  • Patients with history of previous surgery in the inguino-scrotal region
  • Patients who underwent any other surgery concurrent with laparoscopic inguinal hernia repair.

结局指标

主要结局

To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Postoperative pain (Postoperative day 0,1,2), Chronic groin pain, Seroma formation

时间窗: Day 0, Day 1, Day 2

次要结局

  • To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Hospital stay, Other intraoperative & postoperative complications, Mesh infection, Time to return to routine activities, Recurrence(1 month, 3 months, 6 months)

研究者

发起方
Kodidala Sri Charitha
申办方类型
Other [self]

研究点 (1)

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