NCT02632097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

December 13, 2015

Last Update Submit

March 1, 2017

Conditions

Inguinal Hernia

Keywords

inguinal herniamesh fixationgluecyanoacrylateLichtensteinambulatory surgery

Outcome Measures

Primary Outcomes (2)

  • Acute Postoperative Pain

    pain scores (VAS 0-10) after surgery

    30 days

  • Operating Time

    operating time needed to perform hernioplasty

    30 days

Secondary Outcomes (4)

  • Postoperative Complications

    30 days

  • Early Recurrence Rate

    1 year

  • Chronic Pain

    1 year

  • Late Recurrence Rate

    5 years

Study Arms (2)

Histoacryl

EXPERIMENTAL

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

Suture

EXPERIMENTAL

Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun)

Procedure: Lichtenstein Hernioplasty with Sutures

Interventions

Lichtenstein Hernioplasty with HistoacrylPROCEDURE

Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl: 0.5 ml of cyanoacrylate glue is used for mesh fixation

Histoacryl
Lichtenstein Hernioplasty with SuturesPROCEDURE

Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0

Suture

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral inguinal hernia
  • primary hernia

You may not qualify if:

  • femoral hernia
  • recurrent inguinal hernia
  • immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
  • chronic renal failure (hemodialysis)
  • active infection
  • pregnancy
  • allergy to polypropylene
  • patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Plató

Barcelona, Barcelona, 08006, Spain

Location

Related Publications (4)

  • Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989 Feb;157(2):188-93. doi: 10.1016/0002-9610(89)90526-6.

    PMID: 2916733BACKGROUND

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

    BACKGROUND

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes 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 experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PMID: 19638912RESULT

  • Hoyuela C, Juvany M, Carvajal F, Veres A, Troyano D, Trias M, Martrat A, Ardid J, Obiols J, Lopez-Cano M. Randomized clinical trial of mesh fixation with glue or sutures for Lichtenstein hernia repair. Br J Surg. 2017 May;104(6):688-694. doi: 10.1002/bjs.10488. Epub 2017 Feb 20.

    PMID: 28218406DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

EnbucrilateSutures

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyanoacrylatesAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and AgricultureSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Carlos Hoyuela, MD

    Hospital Plató

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 16, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)