NCT03678272

Brief Summary

To evaluate the postoperative pain and the relapse after the repair of the inguinal hernia by Lichtenstein technique with four different mesh types with different types of fixation in patients undergoing major ambulatory surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

1.9 years

First QC Date

January 30, 2017

Last Update Submit

September 18, 2018

Conditions

Inguinal HerniaInguinal Hernia RepairOpen Inguinal Hernia

Keywords

Inguinal herniaChronic postoperative inguinal painGlue meshSuture mesh

Outcome Measures

Primary Outcomes (3)

  • Pain to the month.

    Pain measured by visual analog scale. The pain will be measured one month after surgery.

    One month.

  • Pain to the sixth month

    Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.

    Six months.

  • Pain a year

    Pain measured by visual analog scale. Pain will be measured after the year of surgery.

    One year.

Secondary Outcomes (6)

  • Recurrence

    One year.

  • Surgical time.

    Intraoperative

  • Hypoaesthesia to the month.

    One month.

  • Hypoesthesia at the sixth month.

    Six months.

  • Hypoesthesia at one year.

    One year.

  • +1 more secondary outcomes

Study Arms (4)

HERNIOPLASTY WITH PANAVALE MESH

ACTIVE COMPARATOR

Preformed polypropylene mesh.

Procedure: HERNIOPLASTY WITH PANAVALE MESH

HERNIOPLASTY WITH PARIETEX PROGRIP MESH

ACTIVE COMPARATOR

Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.

Procedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESH

HERNIOPLASTY WITH ADHESIX MESH

ACTIVE COMPARATOR

Self-adhesive mesh.

Procedure: HERNIOPLASTY WITH ADHESIX MESH

HERNIOPLASTY WITH TIMESH MESH

ACTIVE COMPARATOR

Titaniumized polypropylene mesh.

Procedure: HERNIOPLASTY WITH TIMESH MESH

Interventions

HERNIOPLASTY WITH PANAVALE MESHPROCEDURE

Polypropylene mesh fixed with 3 points. Preformed polypropylene mesh will be used by fixing it with one point to the pubis, another to the inguinal ligament and another to the joint tendon.

Also known as: Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
HERNIOPLASTY WITH PANAVALE MESH
HERNIOPLASTY WITH PARIETEX PROGRIP MESHPROCEDURE

Preformed polypropylene mesh will be used which presents a self adhesive system not based on glue, but on the arrangement of the fibers of the mesh as "hooks", and to which we will give a single point to the pubis.

Also known as: Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
HERNIOPLASTY WITH ADHESIX MESHPROCEDURE

It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.

HERNIOPLASTY WITH ADHESIX MESH
HERNIOPLASTY WITH TIMESH MESHPROCEDURE

Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.

Also known as: Ifabond Synthetic Surgical Adhesive 1,5 ml (Péters Surgical)
HERNIOPLASTY WITH TIMESH MESH

Eligibility Criteria

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

You may qualify if:

  • Age: over 18 years
  • Patients undergoing INGUINAL HERNIA surgery on a scheduled basis in surgery without hospitalization.
  • Sign informed consent.
  • ASA I-II.
  • Inguinal hernia.
  • Unilateral or bilateral hernia.
  • Lichtenstein hernia repair technique

You may not qualify if:

  • Patients with ASA III-IV.
  • Psychiatric disorders.
  • Pregnant or breastfeeding.
  • Non-acceptance of informed consent.
  • No acceptance or inability to follow a follow-up protocol.
  • Any hernia repair technique other than Lichtenstein.
  • Recurrent inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

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
PRINCIPAL INVESTIGATOR
PI Title
Head of General surgery

Study Record Dates

First Submitted

January 30, 2017

First Posted

September 19, 2018

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

September 19, 2018

Record last verified: 2018-09