Parietex Progrip Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Sofradim Production.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Covidien
Information provided by:
Sofradim Production
ClinicalTrials.gov Identifier:
NCT00827944
First received: January 22, 2009
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Hernia, Inguinal
Device: Parietex Progrip
Device: Low weight polypropylene mesh
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia

Resource links provided by NLM:


Further study details as provided by Sofradim Production:

Primary Outcome Measures:
  • Pain assessment during the first three months and at one year after surgery using a visual analogue scale (VAS) and a Surgical Pain Scales [ Time Frame: Preop, discharge, D7, M1, M3, M12 months after surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain inducing social consequences using the Activity Assessment Scale investigating functional status [ Time Frame: Preop, M1, M3, M12 months after surgery. ] [ Designated as safety issue: No ]
  • Foreign body sensation [ Time Frame: M1, M3, M12 months after surgery. ] [ Designated as safety issue: No ]
  • Chronic pain defined as pain lasting more than 3 months using VAS score. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Wound complications and hernia recurrences [ Time Frame: Whole follow up ] [ Designated as safety issue: Yes ]
  • Other post-operative complications [ Time Frame: Whole follow up ] [ Designated as safety issue: Yes ]
  • Return to normal daily activities and to work [ Time Frame: Effective date ] [ Designated as safety issue: No ]
  • Safety (incidence of serious adverse events and serious incidents) [ Time Frame: Whole follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: October 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Eligibility

Ages Eligible for Study:   31 Years to 74 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  • bBilateral inguinal hernia
  • Recurrence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827944

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

No publications provided

Responsible Party: BECKER Patrice, Sofradim Production
ClinicalTrials.gov Identifier: NCT00827944     History of Changes
Other Study ID Numbers: SC 0607/1
Study First Received: January 22, 2009
Last Updated: May 16, 2012
Health Authority: Germany: Ethics Commission
Sweden: Regional Ethical Review Board
Netherlands: Medical Ethics Review Committee (METC)
United Kingdom: Research Ethics Committee
Belgium: Institutional Review Board

Keywords provided by Sofradim Production:
Uncomplicated primary inguinal hernias

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 27, 2014