Mesh fixation with glue in the inguinal hernia repair. Does it provide benefits to suture fixation?

Effect of N-Butyl-2 cyanoacrylate for mesh fixation in Lichtenstein hernioplasty on pain, surgical time, recurrence and complications.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000242426

Acronym

FELIU

Enrollment

140

Registered

2016-02-22

Start date

2013-11-26

Completion date

2015-04-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Randomized Clinical Trial, in which they have included patients with unilateral inguinal hernia, elective surgery, over 18 years and agreed to be included. Patients were randomized to one of two treatment groups: Mesh fixation with nonabsorbable sutures or fixation with n- butyl-2 - cyanoacrylate. They have been collected from the patient 's own variables and associated with the intervention. The main objective is to assess the impact on acute pain, secondary objectives are to assess chronic pain and the incidence of hernia recurrence. Pain was assessed using the visual analog scale at each patient visit. Recurrent hernia has been evaluated by physical examination in consultation, in case of doubt has been requested inguinal ultrasound. We observed lower incidence of acute pain in the group of mesh fixation with cyanoacrylate (p<0.05). There were no differences in the development of chronic pain or the incidence of hernia recurrence.

Interventions

Participants are randomised to one of two procedures for hernia repair: 1) Lichtenstein tension-free hernioplasty using N-Butyl-2-cyanoacrylate for mesh fixing or 2) Lichtenstein tension-free hernioplasty using nonabsorbable sutures for mesh fixing. The use of this adhesive is only in the fixation of the mesh. The mesh is fixed using a drop of the N-Butyl-2-cyanoacrylate adhesive in each location where normally a stitch would be placed.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients with unilateral inguinal hernia more than 18 years, electively operated using the technique of Lichtenstein. Patients who accept their inclusion in the study

Exclusion criteria

Patient under 18 or over 80 years, bilateral hernia, emergency surgery other than the Lichtenstein technique. Patients who do not accept their inclusion in the study.

Outcome results