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Impact of Mesh Fixation With Tissue Adhesive

Primary Purpose

Groin Hernia, Hernia, Inguinal, Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Use of n-hexyl cyanoacrylate for mesh fixation
Sponsored by
Hospital Universitario de Móstoles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Groin Hernia focused on measuring hernioplasty, mesh fixation, n-hexyl cyanoacrylate, groin hernia, postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario de MóstolesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tissue adhesive

Standard suture

Arm Description

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

Group of 80 patients who undergo hernioplasty with standard suture

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hernia recurrence
Hernia recurrence rate after mesh fixation with tissue adhesive
Hematoma
Groin hematoma following hernioplasty with n-hexyl cyanoacrylate

Full Information

First Posted
June 12, 2023
Last Updated
June 28, 2023
Sponsor
Hospital Universitario de Móstoles
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1. Study Identification

Unique Protocol Identification Number
NCT05934266
Brief Title
Impact of Mesh Fixation With Tissue Adhesive
Official Title
Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
November 29, 2023 (Anticipated)
Study Completion Date
November 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Móstoles

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Groin Hernia, Hernia, Inguinal, Postoperative Pain, Neuropathic Pain
Keywords
hernioplasty, mesh fixation, n-hexyl cyanoacrylate, groin hernia, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tissue adhesive
Arm Type
Experimental
Arm Description
Group of 80 patients in which mesh fixation is done using cyanoacrylate glue
Arm Title
Standard suture
Arm Type
No Intervention
Arm Description
Group of 80 patients who undergo hernioplasty with standard suture
Intervention Type
Device
Intervention Name(s)
Use of n-hexyl cyanoacrylate for mesh fixation
Intervention Description
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair
Primary Outcome Measure Information:
Title
Postoperative pain assessed by visual numeric scale
Description
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Time Frame
6 months
Title
Postoperative administration of analgesics
Description
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hernia recurrence
Description
Hernia recurrence rate after mesh fixation with tissue adhesive
Time Frame
6 months
Title
Hematoma
Description
Groin hematoma following hernioplasty with n-hexyl cyanoacrylate
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justyna Drewniak
Phone
+34916648600
Ext
8734
Email
justyna.drewniak@salud.madrid.org
Facility Information:
Facility Name
Hospital Universitario de Móstoles
City
Móstoles
State/Province
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justyna Drewniak
Phone
+34916648600
Ext
8734
Email
justyna.drewniak@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Justyna Drewniak

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication

Learn more about this trial

Impact of Mesh Fixation With Tissue Adhesive

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