NCT02748629

Brief Summary

The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.

Trial Health

87
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 Mar 2015

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, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

April 12, 2016

Last Update Submit

October 4, 2016

Conditions

Inguinal Hernia

Keywords

inguinal herniameshlichtensteinhernia repairselfgripping mesh

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-operative pain and its intensity using VAS Scale

    Assessment will be made using Visual Analogue Scale (VAS).

    12 Months

Secondary Outcomes (5)

  • Rate of foreign body sensation - Subjective feeling of discomfort in the groin

    12 Months

  • Hernia recurrence rate

    12 Months

  • Post-operative complications

    12 Months

  • Duration of surgery

    Day of surgery

  • Incidence of Treatment-Emergent Adverse Events [Safety]

    12 Months

Study Arms (2)

ProGrip Mesh Repair

ACTIVE COMPARATOR

80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation.

Device: Covidien Parietex ProGrip Self-Fixating Mesh

Lichtenstein Operation

ACTIVE COMPARATOR

80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (\<40 g/m2) with standard Lichtenstein technique.

Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)

Interventions

Covidien Parietex ProGrip Self-Fixating MeshDEVICE
ProGrip Mesh Repair
Lightweight Polypropylene Mesh (<38g/m2 after absorption)DEVICE

Serag Wiessner SERAMESH® PA 15x10 cm

Lichtenstein Operation

Eligibility Criteria

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

You may qualify if:

  • All patients with primary inguinal hernia
  • Signed consent

You may not qualify if:

  • Recurrent hernia
  • Emergency procedure
  • Patient not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Health Center in Kartuzy

Kartuzy, 83-300, Poland

Location

Related Publications (1)

  • Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.

    PMID: 25146918RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mateusz T Zamkowski, MD

    Regional Health Center in Kartuzy, Department of General Surgery

    STUDY CHAIR

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
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 22, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

PL(1)