Impact of Mesh Fixation With Tissue Adhesive

NCT ID: NCT05934266

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2026-05-29

Brief Summary

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

Detailed Description

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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

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Groin Hernia Hernia, Inguinal Postoperative Pain Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tissue adhesive

Group of 80 patients in which mesh fixation is done using cyanoacrylate glue

Group Type EXPERIMENTAL

Use of n-hexyl cyanoacrylate for mesh fixation

Intervention Type DEVICE

Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair

Standard suture

Group of 80 patients who undergo hernioplasty with standard suture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of n-hexyl cyanoacrylate for mesh fixation

Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de Móstoles

OTHER

Sponsor Role lead

Responsible Party

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Justyna Drewniak Jakubowska

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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HUMostoles

Identifier Type: -

Identifier Source: org_study_id

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