Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
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.
Time frame: 6 months
Postoperative administration of analgesics
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Time frame: 6 months
Hernia recurrence
Hernia recurrence rate after mesh fixation with tissue adhesive
Time frame: 6 months
Hematoma
Groin hematoma following hernioplasty with n-hexyl cyanoacrylate
Time frame: 1 month
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