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

Inguinal Hernia Clinical Trial

— Histoacryl1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632097
• Other study ID #: Histoacryl1
• Status: Completed
• Phase: N/A
• First received: December 13, 2015
• Last updated: March 1, 2017
• Start date: March 2013
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Hospital Plató
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Lichtenstein Hernioplasty with Histoacryl
Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl: 0.5 ml of cyanoacrylate glue is used for mesh fixation
• Lichtenstein Hernioplasty with Sutures
Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0

Locations

Country	Name	City	State
Spain	Hospital Plató	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Plató

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Amid PK, Lichtenstein IL. Long-term results and current status of the Lichtenstein open tension-free hernioplasty. Hernia 1998; 2: 89-94

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year exper — View Citation

Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989 Feb;157(2):188-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Postoperative Pain	pain scores (VAS 0-10) after surgery	30 days
Primary	Operating Time	operating time needed to perform hernioplasty	30 days
Secondary	Postoperative Complications	Complications related to procedure and assessed according to Clavien-Dindo Classification	30 days
Secondary	Early Recurrence Rate	Inguinal hernia recurrence rate after 1 year follow-up	1 year
Secondary	Chronic Pain	Pain scores (0-10) after 1-year follow-up	1 year
Secondary	Late Recurrence Rate	Inguinal hernia recurrence rate after 5 years follow-up	5 years