ProGrip Mesh Repair vs Lichtenstein Operation

October 4, 2016 updated by: Regional Health Center in Kartuzy, Poland

Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Kartuzy, Poland, 83-300
        • Regional Health Center in Kartuzy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with primary inguinal hernia
  • Signed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ProGrip Mesh Repair
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
Active Comparator: Lichtenstein Operation
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)
Serag Wiessner SERAMESH® PA 15x10 cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-operative pain and its intensity using VAS Scale
Time Frame: 12 Months
Assessment will be made using Visual Analogue Scale (VAS).
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of foreign body sensation - Subjective feeling of discomfort in the groin
Time Frame: 12 Months
Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.
12 Months
Hernia recurrence rate
Time Frame: 12 Months
Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)
12 Months
Post-operative complications
Time Frame: 12 Months
Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)
12 Months
Duration of surgery
Time Frame: Day of surgery
Day of surgery
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Health Center in Kartuzy, Poland

Collaborators

Medical University of Gdansk

Investigators

  • Study Chair: Mateusz T Zamkowski, MD, Regional Health Center in Kartuzy, Department of General Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKBNN/258/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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