Impact of Mesh Fixation With Tissue Adhesive

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934266
• Other study ID #: HUMostoles
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Groin Hernia
• Hernia
• Hernia, Inguinal
• Neuralgia
• Neuropathic Pain
• Pain, Postoperative
• Postoperative Pain

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