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Parietex Progrip Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827944
First Posted: January 23, 2009
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Medtronic - MITG:

Primary Outcome Measures:
  • Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) [ Time Frame: M3, M12 after surgery ]
    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.

  • Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) [ Time Frame: M3, M12 after surgery ]
    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).


Secondary Outcome Measures:
  • Foreign Body Sensation [ Time Frame: M1, M3, M12 months after surgery ]
    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.

  • Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score [ Time Frame: 3 months after surgery ]
    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.

  • Wound Complications and Hernia Recurrences [ Time Frame: M12 after surgery ]
  • Return to Work and to Normal Daily Activities [ Time Frame: Effective date ]
  • Other Post-operative Complications [ Time Frame: M12 after surgery ]

Enrollment: 603
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: October 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   31 Years to 74 Years   (Adult, Senior)
Sexes 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
  • Bilateral inguinal hernia
  • Recurrence
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Medtronic - MITG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00827944     History of Changes
Other Study ID Numbers: SC 0607/1
First Submitted: January 22, 2009
First Posted: January 23, 2009
Results First Submitted: August 23, 2013
Results First Posted: November 17, 2016
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by Medtronic - MITG:
Uncomplicated primary inguinal hernias

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