Clinical trial NCT00827944: Parietex Progrip Study
Official title: ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia, Inguinal
Keywords: Uncomplicated primary inguinal hernias
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 603
Sex: MALE
Minimum age (years): 31
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
timeFrame: M3, M12 after surgery
measure: Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
timeFrame: M3, M12 after surgery
Secondary outcomes:
measure: Foreign Body Sensation
timeFrame: M1, M3, M12 months after surgery
measure: Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score
timeFrame: 3 months after surgery
measure: Wound Complications and Hernia Recurrences
timeFrame: M12 after surgery
measure: Return to Work and to Normal Daily Activities
timeFrame: Effective date
measure: Other Post-operative Complications
timeFrame: M12 after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Fulda
country: Germany
facility: Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik
city: Eindhoven
country: Netherlands
facility: Catharina-ziekenhuis
city: Linköping
country: Sweden
facility: Medical Center Linköping
city: Västeras-
country: Sweden
facility: Centre of clinical research
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: London
country: United Kingdom
facility: Imperial College London / Faculty of Medecine
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
References:
citation: 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.