Impact of Mesh Fixation With Tissue Adhesive

NCT05934266 | Active Not Recruiting Phase 4

• 1 other identifier: HUMostoles
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

hernioplasty; mesh fixation; n-hexyl cyanoacrylate; groin hernia; postoperative pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Hernia recurrence

  6 months

• Hematoma

  1 month

Study Arms (2)

Tissue adhesive

EXPERIMENTAL

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

Device: Use of n-hexyl cyanoacrylate for mesh fixation

Standard suture

NO INTERVENTION

Group of 80 patients who undergo hernioplasty with standard suture

Interventions

Use of n-hexyl cyanoacrylate for mesh fixation DEVICE

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

Tissue adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective open inguinal hernioplasty in patients over 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Móstoles: lead

Study Sites (1)

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 6, 2023
• Study Start: March 29, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 29, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)