Impact of Mesh Fixation With Tissue Adhesive

Study Overview
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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.

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

Conditions
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Groin Hernia, Hernia, Inguinal, Postoperative Pain, Neuropathic Pain

Intervention / Treatment
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* Device: Use of n-hexyl cyanoacrylate for mesh fixation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue adhesive<br>Group of 80 patients in which mesh fixation is done using cyanoacrylate glue | Device: Use of n-hexyl cyanoacrylate for mesh fixation<br>* Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair<br>|
| No Intervention: Standard suture<br>Group of 80 patients who undergo hernioplasty with standard suture | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | Hernia recurrence rate after mesh fixation with tissue adhesive | 6 months | 
| Hematoma | Groin hematoma following hernioplasty with n-hexyl cyanoacrylate | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernioplasty, mesh fixation, n-hexyl cyanoacrylate, groin hernia, postoperative pain