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临床试验/CTRI/2024/11/077136
CTRI/2024/11/077136尚未招募不适用

Comparison Of N-butyl 2-cyanoacrylate Glue Fixation Versus Conventional Fixation of Polypropylene Mesh In Patients Undergoing Lichtenstein Repair For Inguinal Hernia: A Randomized Control Trial.

DrSyed arif1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To show mesh fixation using n-butyl 2-cyanoacrylate glue gives better outcome than conventional mesh fixation in open hernia repair in terms of post operative groin pain score at 24hrs, 72hrs, 7days, 15days 1month and 3 month post op follow up.

研究概览

简要总结

Inguinal hernia is a prevalent surgical issue, affecting 3-8% of the global population, with a lifetime risk of 25% in males and 3% in females. It involves a weakness in the abdominal wall, allowing the protrusion of intra-abdominal contents. Inguinal hernias account for 75% of all hernias, with two-thirds being indirect (through the inguinal canal) and the rest direct (through Hesselbach’s triangle). Historically, various methods have been developed for hernia repair, starting with the strengthening of the external ring and anterior wall by Stormayr in 1559, Purman in 1692, and Czerny in 1877. The Bassini repair in 1887 focused on reconstructing the posterior wall, which was later modified by Shouldice in the 1940s to include four layers of fascia and aponeurosis for added strength.

The most recent and widely used method is the Lichtenstein repair, introduced in 1984 and modified in the 1990s, which uses a polypropylene mesh for tension-free onlay open mesh hernioplasty. However, mesh fixation with prolene suture can lead to complications such as seroma or hematoma formation, increased surgery duration, urinary retention, transient testicular pain and swelling, scrotal edema, infection, post-operative pain (inguinodynia), and rarely, recurrence. Chronic pain can be neuropathic, due to direct nerve damage, perineural fibrosis, or damage from staples, tacks, or suture materials, or non-neuropathic, due to folded mesh, periosteal reaction, or scar tissue formation.

To mitigate these complications, alternative methods for mesh fixation have been developed, including absorbable and non-absorbable tacks, cyanoacrylate or fibrin glues, bovine and porcine gelatin, PEG polymer, bovine albumin cross-linked with glutaraldehyde, lightweight and self-gripping mesh, and laparoscopic fixation, which has been found to reduce post-operative pain due to fewer fixation points. These advancements aim to improve patient outcomes and reduce complications in inguinal hernia repair.

JUSTIFICATION:

Several previous studies have demonstrated that patients in the N butyl 2 cyanoacrylate glue group experienced significantly less postoperative groin pain and shorter surgery duration compared to the Conventional suture group.(7) However, there is a lack of similar studies and awareness regarding the use of glue for mesh fixation in central India population. Therefore, this study aims to compare the efficacy of n butyl 2 cyanoacrylate glue for mesh fixation with conventional mesh fixation in central India group of population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Patients planned for open hernioplasty for uncomplicated inguinal hernia.

排除标准

  • Recurrent inguinal hernia Hernioplasty combined with any additional procedure Patients who are immunocompromised due to any cause.

结局指标

主要结局

To show mesh fixation using n-butyl 2-cyanoacrylate glue gives better outcome than conventional mesh fixation in open hernia repair in terms of post operative groin pain score at 24hrs, 72hrs, 7days, 15days 1month and 3 month post op follow up.

时间窗: 6months follow up

次要结局

  • To document the operative time in both the methods.(To measure the magnitude of chronic groin pain at 03 months follow up.)

研究者

发起方
DrSyed arif
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrSyed arif

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR(AIIMS RAIPUR)

研究点 (1)

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