Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- Acute Postoperative Pain
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Histoacryl
Intervention: Lichtenstein Hernioplasty with Histoacryl™(cyanoacrylate glue 0.5 ml) for mesh fixation (Optilene™ mesh 60 g/m2 (B. Braun))
Intervention: Lichtenstein Hernioplasty with Histoacryl (Procedure)
Suture
Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun)
Intervention: Lichtenstein Hernioplasty with Sutures (Procedure)
Outcomes
Primary Outcomes
Acute Postoperative Pain
Time Frame: 30 days
pain scores (VAS 0-10) after surgery
Operating Time
Time Frame: 30 days
operating time needed to perform hernioplasty
Secondary Outcomes
- Postoperative Complications(30 days)
- Early Recurrence Rate(1 year)
- Chronic Pain(1 year)
- Late Recurrence Rate(5 years)