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临床试验/CTRI/2024/10/074854
CTRI/2024/10/074854尚未招募不适用

A randomised control trial of mesh fixation with polypropylene sutures (prolene) versus polyglactin sutures (vicryl) sutures in assessing inguinodynia in open inguinal hernia repair.

Jawaharlal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Based on the findings of the present study it may be concluded that, using polyglactin suture material to fix mesh is a safe, simple as well as an effective alternative to the conventional usage of polypropylene sutures for fixing the mesh in Lichtenstein hernia repair. The post- operative pain on day 1 and day 3 is similar with both vicryl and prolene sutures but on the day 7 and after 3 months it is significantly less.

研究概览

简要总结

Inguinal hernia, the most frequently occurring type of hernia globally, Chronic groin pain could be related to nerve mangling while operating. Mesh repair can lead to an inflammatory reaction over a period of time, though it still needs ground work to find out exact cause of pain. So this study aims to compare the effectiveness of polyglactin versus prolene sutures in reducing the post-operative pain in inguinal hernia repair. Chronic pain in the groin is a notable problem post Lichtenstien’s repair, even though the pain is usually mild, studies have revealed that irrespective of the severity, chronic pain may considerably hamper day to day activity.  Chronic pain is the principle issue linked with the Lichtenstein technique with a conclusive rate between 15% and 40%. Routine usage of absorbable sutures to fix mesh in Lichtenstien’s repair have resulted in reduce post- operative chronic pain, yet controversies persist. So we took up this study to appraise post-operative groin pain in the patients where polyglactin sutures were used to fix the mesh (group A) versus polypropylene sutures in doing the same (group B) in Lichtenstein inguinal hernia repair. There have been many theories regarding the causes for the groin pain and one plausible theory is pain after surgery persists for a long period due to is inflammatory changes, fibrosis, subsequently entrapment of nerve, induced either by mesh or suture material, that’s in proximity of ilioinguinal nerve. Apart from this untimely mangling to nerve at the time of dissection may contribute as well to this. Vicryl (polyglactin) is a synthetic, absorbable, braided suture which can sustain its tensile strength for nearly 3 to 4 weeks in tissues. It’s entirely absorbed by hydrolysis within 60 days.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Male

入选标准

  • Inclusion Criteria:
  • Primary inguinal hernia
  • Uncomplicated hernia
  • Age range of 18 to 70 years
  • Unilateral or bilateral inguinal hernia
  • Nerve identification.

排除标准

  • Exclusion criteria Irreducible hernias, patients with bleeding disorders, patients on anticoagulant treatment, pregnancy, patients needing emergency repair, HIV and HbsAg positive patients.

结局指标

主要结局

Based on the findings of the present study it may be concluded that, using polyglactin suture material to fix mesh is a safe, simple as well as an effective alternative to the conventional usage of polypropylene sutures for fixing the mesh in Lichtenstein hernia repair. The post- operative pain on day 1 and day 3 is similar with both vicryl and prolene sutures but on the day 7 and after 3 months it is significantly less.

时间窗: Post operative day 1, 3, 7 and 3 months

次要结局

  • Hence our study helps use to understand the benefits of using polyglactin sutures & also enables us to recommend its application to fix the mesh in Lichtenstien’s hernioplasty. So, routine usage of polyglactin (vicryl) sutures for mesh fixation in a Lichtenstien’s hernioplasty is safe & simple & thus a reasonable option.

研究者

申办方类型
Private medical college

研究点 (1)

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