Histoacryl™ vs. Suture for Mesh Fixation in Lichtenstein Hernioplasty: A Randomized Prospective Double-Blinded Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Hypothesis: To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain. The use of Histoacryl is associated to a lower postoperative complications rate. 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.

Official Title
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Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Lichtenstein Hernioplasty with Histoacryl
* Procedure: Lichtenstein Hernioplasty with Sutures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Histoacryl<br>Intervention: Lichtenstein Hernioplasty with Histoacryl™(cyanoacrylate glue 0.5 ml) for mesh fixation (Optilene™ mesh 60 g/m2 (B. Braun)) | Procedure: Lichtenstein Hernioplasty with Histoacryl<br>* Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl: 0.5 ml of cyanoacrylate glue is used for mesh fixation<br>|
| Experimental: Suture<br>Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun) | Procedure: Lichtenstein Hernioplasty with Sutures<br>* Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Postoperative Pain | pain scores (VAS 0-10) after surgery | 30 days | 
| Operating Time | operating time needed to perform hernioplasty | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | Complications related to procedure and assessed according to Clavien-Dindo Classification | 30 days | 
| Early Recurrence Rate | Inguinal hernia recurrence rate after 1 year follow-up | 1 year | 
| Chronic Pain | Pain scores (0-10) after 1-year follow-up | 1 year | 
| Late Recurrence Rate | Inguinal hernia recurrence rate after 5 years follow-up | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, mesh fixation, glue, cyanoacrylate, Lichtenstein, ambulatory surgery