ProGrip Mesh Repair vs Lichtenstein Operation

NCT ID: NCT02748629

Last Updated: 2016-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.

Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ProGrip Mesh Repair

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

Group Type ACTIVE_COMPARATOR

Covidien Parietex ProGrip Self-Fixating Mesh

Intervention Type DEVICE

Lichtenstein Operation

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Serag Wiessner SERAMESH® PA 15x10 cm

Interventions

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Covidien Parietex ProGrip Self-Fixating Mesh

Intervention Type DEVICE

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

Serag Wiessner SERAMESH® PA 15x10 cm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with primary inguinal hernia
* Signed consent

Exclusion Criteria

* Recurrent hernia
* Emergency procedure
* Patient not willing to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role collaborator

Regional Health Center in Kartuzy, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mateusz T Zamkowski, MD

Role: STUDY_CHAIR

Regional Health Center in Kartuzy, Department of General Surgery

Locations

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Regional Health Center in Kartuzy

Kartuzy, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type RESULT
PMID: 25146918 (View on PubMed)

Other Identifiers

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NKBNN/258/2015

Identifier Type: -

Identifier Source: org_study_id

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