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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue adhesive | Experimental | Group of 80 patients in which mesh fixation is done using cyanoacrylate glue |
|
| Standard suture | No Intervention | Group of 80 patients who undergo hernioplasty with standard suture |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of n-hexyl cyanoacrylate for mesh fixation | Device | Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Postoperative administration of analgesics | Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia recurrence | Hernia recurrence rate after mesh fixation with tissue adhesive | 6 months |
| Hematoma | Groin hematoma following hernioplasty with n-hexyl cyanoacrylate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Móstoles | Móstoles | Madrid | Spain |
All IPD that underlie results in a publication
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 month |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |