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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05934266
Other study ID # HUMostoles
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 29, 2023
Est. completion date November 29, 2023

Study information

Verified date June 2023
Source Hospital Universitario de Móstoles
Contact Justyna Drewniak
Phone +34916648600
Email justyna.drewniak@salud.madrid.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date November 29, 2023
Est. primary completion date November 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Use of n-hexyl cyanoacrylate for mesh fixation
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair

Locations

Country Name City State
Spain Hospital Universitario de Móstoles Móstoles Madrid

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario de Móstoles

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Postoperative administration of analgesics Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements 6 months
Secondary Hernia recurrence Hernia recurrence rate after mesh fixation with tissue adhesive 6 months
Secondary Hematoma Groin hematoma following hernioplasty with n-hexyl cyanoacrylate 1 month
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