Impact of Mesh Fixation With Tissue Adhesive

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Hernia, Inguinal; Neuropathic Pain; Groin Hernia
• Intervention / Treatment: Device: Use of n-hexyl cyanoacrylate for mesh fixation

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Justyna Drewniak; Phone Number: 8734 +34916648600; Email: justyna.drewniak@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • Móstoles, Madrid, Spain
      • Recruiting
      • Hospital Universitario de Móstoles
      • Contact: Justyna Drewniak; Phone Number: 8734 +34916648600; Email: justyna.drewniak@salud.madrid.org
      • Principal Investigator: Justyna Drewniak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario de Móstoles

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): November 29, 2023
• Study Completion (Estimated): November 29, 2023

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: postoperative pain; mesh fixation; groin hernia; hernioplasty; n-hexyl cyanoacrylate
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Hernia, Inguinal; Neuralgia
• Other Study ID Numbers: HUMostoles

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No