Impact of Mesh Fixation With Tissue Adhesive

Phase 4

Active, not recruiting

• Conditions: Postoperative Pain; Neuropathic Pain; Hernia, Inguinal; Groin Hernia
• Interventions: Device: Use of n-hexyl cyanoacrylate for mesh fixation

• Registration Number: NCT05934266
• Lead Sponsor: Hospital Universitario de Móstoles

Brief 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.

Study Timeline

• Study Start: 2023-03-29
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-06
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Study Completion: 2026-05-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Elective open inguinal hernioplasty in patients over 18 years old

Exclusion Criteria

• Patient refusal
• Laparoscopic surgery
• Reintervention surgery
• Urgent surgery
• Cyanoacrylate allergy
• Administration of intraoperative local anesthetics
• Comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue adhesive	Use of n-hexyl cyanoacrylate for mesh fixation	Group of 80 patients in which mesh fixation is done using cyanoacrylate glue

Primary Outcome Measures

Name	Time	Method
Postoperative administration of analgesics	6 months	Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Postoperative pain assessed by visual numeric scale	6 months	Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.

Secondary Outcome Measures

Name	Time	Method
Hernia recurrence	6 months	Hernia recurrence rate after mesh fixation with tissue adhesive
Hematoma	1 month	Groin hematoma following hernioplasty with n-hexyl cyanoacrylate

Trial Locations

Locations (1)

Hospital Universitario de Móstoles; 🇪🇸 Móstoles, Madrid, Spain