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Completed

NCT Number: NCT00827944

Parietex Progrip Study

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.

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

31 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parietex Progrip

Device

Surgical technique:

Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.

Low weight polypropylene mesh

Device

Surgical technique:

Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. Wound Complications and Hernia Recurrences

    Time frame: M12 after surgery

  4. Return to Work and to Normal Daily Activities

    Time frame: Effective date

  5. Other Post-operative Complications

    Time frame: M12 after surgery

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2009
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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