Parietex Progrip Study - Full Text View

Sponsors and Collaborators:	Sofradim Production Covidien
Information provided by:	Sofradim Production
ClinicalTrials.gov Identifier:	NCT00827944

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 IV

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Active Control, Parallel Assignment, Randomized, Safety/Efficacy Study, Single Blind (Subject), Treatment
Official Title:	ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia

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 ]
Safety (incidence of serious adverse events and serious incidents) [ 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 ]
Wound complications and hernia recurrences [ Time Frame: Whole follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Parietex ProGrip	Device: Parietex Progrip Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
2: Active Comparator 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

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

Contacts

Contact: Elodie Franchimont, Sr CRA	+33 4 74 08 78 95	elodie.franchimont@covidien.com
Contact: Patrice Becker, Clinical Research Director	+33 4 74 08 92 38	patrice.becker@covidien.com

Locations

Germany
Klinikum Bremen-Mitte	Recruiting
Bremen, Germany, 28177
Contact: Silke SCHÜLE, Doctor +49 421 497 3256 silke.schuele@klinikum-bremen-mitte.de
Principal Investigator: Silke SCHÜLE, Doctor
Netherlands
Catharina-ziekenhuis	Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Loes Van den Nieuwenhof, Study Nurse +31 40 2397159 loes.biesheuvel@catharina-ziekenhuis.nl
Principal Investigator: Simon NIENHUIJS, Doctor
Sweden
Medical Center Linköping	Recruiting
Linköping, Sweden, 582 24
Contact: Staffan SMEDS, Professor + 46 13 376 027 staffan.smeds@medcentrum.se
Principal Investigator: Staffan SMEDS, Professor
United Kingdom
Derriford Hospital	Recruiting
Plymouth, United Kingdom, PL6
Contact: Maggie Gavasingha, Study Nurse + 44 1752 439295 Maggie.Gavasingha@phnt.swest.nhs.uk
Principal Investigator: Andrew KINGSNORTH, Professor
Western Infirmary	Not yet recruiting
Glasgow, United Kingdom, G11 6NT
Contact: Gwen TOMSON, secretary +44 141 211 2804 gwen.thomson@ggc.scot.nhs.uk
Principal Investigator: Patrick Joseph O'DWYER, Professor

Sponsors and Collaborators

Sofradim Production

Covidien

More Information

No publications provided

Responsible Party:	Sofradim Production ( BECKER Patrice )
Study ID Numbers:	SC 0607/1
Study First Received:	January 22, 2009
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00827944 History of Changes
Health Authority:	Germany: Ethics Commission; Netherlands: Medical Ethics Review Committee (METC); Sweden: Regional Ethical Review Board; United Kingdom: Research Ethics Committee; United States: Institutional Review Board

Keywords provided by Sofradim Production:

Uncomplicated primary inguinal hernias

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Inguinal

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Inguinal

ClinicalTrials.gov processed this record on March 16, 2009