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OpenTrials
Active, Not Recruiting

NCT Number: NCT05934266

Impact of Mesh Fixation With Tissue Adhesive

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of n-hexyl cyanoacrylate for mesh fixation

Device

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

Primary outcomes

  1. Postoperative pain assessed by visual numeric scale

    Time frame: 6 months

    Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.

  2. Postoperative administration of analgesics

    Time frame: 6 months

    Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements

Secondary outcomes

  1. Hernia recurrence

    Time frame: 6 months

    Hernia recurrence rate after mesh fixation with tissue adhesive

  2. Hematoma

    Time frame: 1 month

    Groin hematoma following hernioplasty with n-hexyl cyanoacrylate

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Móstoles

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 6, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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