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Impact of Mesh Fixation With Tissue Adhesive

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ClinicalTrials.gov Identifier: NCT05934266
Recruitment Status : Recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
Justyna Drewniak Jakubowska, Hospital Universitario de Móstoles

Study Description
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Brief Summary:
Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.

Condition or disease Intervention/treatment Phase
Groin Hernia Hernia, Inguinal Postoperative Pain Neuropathic Pain Device: Use of n-hexyl cyanoacrylate for mesh fixation Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
Actual Study Start Date : March 29, 2023
Estimated Primary Completion Date : November 29, 2023
Estimated Study Completion Date : November 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05934266


Contacts
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Contact: Justyna Drewniak +34916648600 ext 8734 justyna.drewniak@salud.madrid.org

Locations
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Spain
Hospital Universitario de Móstoles Recruiting
Móstoles, Madrid, Spain
Contact: Justyna Drewniak    +34916648600 ext 8734    justyna.drewniak@salud.madrid.org   
Principal Investigator: Justyna Drewniak         
Sponsors and Collaborators
Hospital Universitario de Móstoles
More Information
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Responsible Party: Justyna Drewniak Jakubowska, Surgeon, Hospital Universitario de Móstoles
ClinicalTrials.gov Identifier: NCT05934266    
Other Study ID Numbers: HUMostoles
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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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
Keywords provided by Justyna Drewniak Jakubowska, Hospital Universitario de Móstoles:
hernioplasty
mesh fixation
n-hexyl cyanoacrylate
groin hernia
postoperative pain
Additional relevant MeSH terms:
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Neuralgia
Pain, Postoperative
Hernia
Hernia, Inguinal
Postoperative Complications
Pathologic Processes
Pain
 Neurologic Manifestations
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Hernia, Abdominal