Clinical Trial: Parietex Progrip Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

  • 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.

Sponsor: Medtronic - MITG

Current Primary Outcome:

  • 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).


Original Primary Outcome: 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. ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Pain inducing social consequences using the Activity Assessment Scale investigating functional status [ Time Frame: Preop, M1, M3, M12 months after surgery. ]
  • Foreign Body Sensation [ Time Frame: M1, M3, M12 months after surgery. ]
  • Chronic pain defined as pain lasting more than 3 months using VAS score. [ Time Frame: 3 months ]
  • Wound Complications and Hernia Recurrences [ Time Frame: Whole follow up ]
  • Other Post-operative Complications [ Time Frame: Whole follow up ]
  • Return to normal daily activities and to work [ Time Frame: Effective date ]
  • Safety (incidence of serious adverse events and serious incidents) [ Time Frame: Whole follow up ]


Information By: Medtronic - MITG

Dates:
Date Received: January 22, 2009
Date Started: October 2008
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016