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ProGrip Mesh Repair vs Lichtenstein Operation

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Covidien Parietex ProGrip Self-Fixating Mesh
Lightweight Polypropylene Mesh (<38g/m2 after absorption)
Sponsored by
Regional Health Center in Kartuzy, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, mesh, lichtenstein, hernia repair, selfgripping mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with primary inguinal hernia
  • Signed consent

Exclusion Criteria:

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

Sites / Locations

  • Regional Health Center in Kartuzy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ProGrip Mesh Repair

Lichtenstein Operation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of post-operative pain and its intensity using VAS Scale
Assessment will be made using Visual Analogue Scale (VAS).

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2016
Last Updated
October 4, 2016
Sponsor
Regional Health Center in Kartuzy, Poland
Collaborators
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT02748629
Brief Title
ProGrip Mesh Repair vs Lichtenstein Operation
Official Title
Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regional Health Center in Kartuzy, Poland
Collaborators
Medical University of Gdansk

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, mesh, lichtenstein, hernia repair, selfgripping mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProGrip Mesh Repair
Arm Type
Active Comparator
Arm Description
80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation.
Arm Title
Lichtenstein Operation
Arm Type
Active Comparator
Arm Description
80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (<40 g/m2) with standard Lichtenstein technique.
Intervention Type
Device
Intervention Name(s)
Covidien Parietex ProGrip Self-Fixating Mesh
Intervention Type
Device
Intervention Name(s)
Lightweight Polypropylene Mesh (<38g/m2 after absorption)
Intervention Description
Serag Wiessner SERAMESH® PA 15x10 cm
Primary Outcome Measure Information:
Title
Incidence of post-operative pain and its intensity using VAS Scale
Description
Assessment will be made using Visual Analogue Scale (VAS).
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Rate of foreign body sensation - Subjective feeling of discomfort in the groin
Description
Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.
Time Frame
12 Months
Title
Hernia recurrence rate
Description
Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)
Time Frame
12 Months
Title
Post-operative complications
Description
Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)
Time Frame
12 Months
Title
Duration of surgery
Time Frame
Day of surgery
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with primary inguinal hernia Signed consent Exclusion Criteria: Recurrent hernia Emergency procedure Patient not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mateusz T Zamkowski, MD
Organizational Affiliation
Regional Health Center in Kartuzy, Department of General Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Health Center in Kartuzy
City
Kartuzy
ZIP/Postal Code
83-300
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25146918
Citation
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.
Results Reference
result

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ProGrip Mesh Repair vs Lichtenstein Operation

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