Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty
| Registry | NCT02632097, acronym Histoacryl1 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 370 (Actual) |
| Sponsor | Hospital Plató (Other) |
| Conditions | Inguinal Hernia |
| Interventions | Lichtenstein Hernioplasty with Histoacryl, Lichtenstein Hernioplasty with Sutures (Procedure) |
| Dates | start 2013-03-01, primary completion 2016-12-01, completion 2017-01-01, first posted 2015-12-16, last updated 2017-03-03 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Inguinal Hernia All trials of Lichtenstein Hernioplasty with Histoacryl All trials of Lichtenstein Hernioplasty with Sutures
This is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is that glue fixation is safe, simple and fast method compared to conventional Lichtenstein technique.
Hypothesis:
1. To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain.
2. The use of Histoacryl is associated to a lower postoperative complications rate.
3. The use of Histoacryl is not associated to a higher hernia recurrence rate.
Methods:
350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacryl™ (n=175: Group H), and non-absorbable sutures: polypropylene 2/0 (n=175: Group S). Operative time and pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years postoperatively.
Surgeon doesn't know previously which fixation method will be used in each patient. This method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind randomization code (www.randomizer.org) Patients are discharged (day-case surgery) if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. Postoperative oral treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1 gr/8.
Follow-up is performed at the medical office by a blind observer (third surgeon) who didn't participate in the surgical procedure, at 1 day, 7 days, 30 days, 1 year and annually thereafter. Pain is measured using a VAS scale (0-10).
Operative data (including operating time, complications, hospital stay, etc.), early and late complications, acute and chronic pain and recurrence rate will be recorded.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Histoacryl | Experimental | Procedure: Lichtenstein Hernioplasty with Histoacryl | Intervention: Lichtenstein Hernioplasty with Histoacryl™(cyanoacrylate glue 0.5 ml) for mesh fixation (Optilene™ mesh 60 g/m2 (B. Braun)) |
| Suture | Experimental | Procedure: Lichtenstein Hernioplasty with Sutures | Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun) |
Sex: All, ages: 18 Years to 85 Years
Inclusion Criteria: * unilateral inguinal hernia * primary hernia Exclusion Criteria: * femoral hernia * recurrent inguinal hernia * immunosuppression (including corticosteroids, radiotherapy, chemotherapy) * chronic renal failure (hemodialysis) * active infection * pregnancy * allergy to polypropylene * patient's refusal
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Plató | Barcelona, Barcelona | Spain |