Groin Hernia, Hernia, Inguinal, Neuropathic Pain, Postoperative Pain
Conditions
Keywords
hernioplasty, mesh fixation, n-hexyl cyanoacrylate, groin hernia, postoperative pain
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.
Interventions
DEVICEUse of n-hexyl cyanoacrylate for mesh fixation
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair
Sponsors
Hospital Universitario de Móstoles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | 6 months | Hernia recurrence rate after mesh fixation with tissue adhesive |
| Hematoma | 1 month | Groin hematoma following hernioplasty with n-hexyl cyanoacrylate |
Countries
Spain
Outcome results
None listed