Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Groin Hernia
- Sponsor
- Hospital Universitario de Móstoles
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Postoperative administration of analgesics
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Justyna Drewniak Jakubowska
Surgeon
Hospital Universitario de Móstoles
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.
Outcomes
Primary Outcomes
Postoperative administration of analgesics
Time Frame: 6 months
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
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.
Secondary Outcomes
- Hernia recurrence(6 months)
- Hematoma(1 month)