Impact of Mesh Fixation With Tissue Adhesive

Hospital Universitario de Móstoles

Status and phase: Active, not recruiting; Phase 4

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

Treatments: Device: Use of n-hexyl cyanoacrylate for mesh fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05934266

HUMostoles

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Tissue adhesive

Experimental group

Description:

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

Treatment:

Device: Use of n-hexyl cyanoacrylate for mesh fixation

Standard suture

No Intervention group

Description:

Group of 80 patients who undergo hernioplasty with standard suture