NCT02500056

Brief Summary

The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 6, 2017

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

July 10, 2015

Results QC Date

April 20, 2016

Last Update Submit

June 8, 2017

Conditions

Inguinal Hernia

Keywords

Inguinal herniaChronic painMeshLichtenstein hernioplasty

Outcome Measures

Primary Outcomes (1)

  • Chronic Pain

    On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise

    6-month follow-up

Secondary Outcomes (2)

  • Chronic Pain

    3-year follow-up

  • Foreign Body Feeling

    6-month follow-up

Study Arms (2)

OM group

ACTIVE COMPARATOR

Optilene LP mesh

Device: Optilene LP mesh

UM group

ACTIVE COMPARATOR

Ultrapro mesh

Device: Ultrapro mesh

Interventions

Optilene LP meshDEVICE

Lichtenstein hernioplasty

OM group
Ultrapro meshDEVICE

Lichtenstein hernioplasty

UM group

Eligibility Criteria

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

You may qualify if:

  • age ≥18 years
  • unilateral primary reducible inguinal hernia
  • elective operation
  • consent to participate in the study.

You may not qualify if:

  • age \<18 years
  • irreducible
  • strangulated
  • recurrent hernia
  • inability to understand the questionnaire
  • unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, InguinalChronic Pain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Ceith Nikkolo
Organization
Tartu University Hospital
ceith.nikkolo@kliinikum.ee
+37253319082

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 16, 2015

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2015

Last Updated

July 11, 2017

Results First Posted

June 6, 2017

Record last verified: 2017-06