Parietex Progrip Study

ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia

The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Device: Parietex Progrip; Device: Low weight polypropylene mesh

Detailed Description

• Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
• Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
• Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
• 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.

• Study Type: Interventional
• Enrollment (Actual): 603
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
• Germany
  • Bremen, Germany, 28177
    • Klinikum Bremen-Mitte
  • Fulda, Germany, D- 36039 Fulda
    • Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina-Ziekenhuis
• Sweden
  • Linköping, Sweden, 582 24
    • Medical Center Linköping
  • Västeras-, Sweden, 721 89
    • Centre of clinical research
• United Kingdom
  • Glasgow, United Kingdom, G11 6NT
    • Western Infirmary
  • London, United Kingdom, W2 1NY
    • Imperial College London / Faculty of Medecine
  • Plymouth, United Kingdom, PL6
    • Derriford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• All male patients at participating centers with a primary, uncomplicated inguinal hernia.
• Collar of the defect ≤ 4 cm
• Signed informed consent

Exclusion Criteria:

• 30 years ≥ Age ≥ 75 years
• Emergency procedure
• Inclusion in other trials
• Bilateral inguinal hernia
• Recurrence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Parietex ProGrip	Device: Parietex Progrip; Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
ACTIVE_COMPARATOR: 2; Low weight polypropylene mesh	Device: Low weight polypropylene mesh; Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)	Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.	M3, M12 after surgery
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)	Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).	M3, M12 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foreign Body Sensation	Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.	M1, M3, M12 months after surgery
Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score	Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.	3 months after surgery
Wound Complications and Hernia Recurrences		M12 after surgery
Return to Work and to Normal Daily Activities		Effective date
Other Post-operative Complications		M12 after surgery

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (ESTIMATE): January 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Uncomplicated primary inguinal hernias
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: SC 0607/1