Postoperative Pain Clinical Trial
Official title:
Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair
Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de Móstoles | Móstoles | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario de Móstoles |
Spain,
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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