Impact of Mesh Fixation With Tissue Adhesive

Sponsor

Hospital Universitario de Móstoles (Other)

Overall Status

Recruiting

CT.gov ID

NCT05934266

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Mar 29, 2023

Anticipated Primary Completion Date :

Nov 29, 2023

Anticipated Study Completion Date :

Nov 29, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Postoperative pain assessed by visual numeric scale [6 months]
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Postoperative administration of analgesics [6 months]
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements

Secondary Outcome Measures

Hernia recurrence [6 months]
Hernia recurrence rate after mesh fixation with tissue adhesive
Hematoma [1 month]
Groin hematoma following hernioplasty with n-hexyl cyanoacrylate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.