NCT05934266

Impact of Mesh Fixation With Tissue Adhesive

Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Hospital Universitario de Móstoles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.

Detailed description

Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain. The objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.

Conditions

• Groin Hernia
• Hernia, Inguinal
• Postoperative Pain
• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Use of n-hexyl cyanoacrylate for mesh fixation	Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-05-01
• Completion: 2026-05-29
• First posted: 2023-07-06
• Last updated: 2025-05-02

Locations

1 site across 1 country: Spain