Parietex Progrip Study

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827944
• Other study ID #: SC 0607/1
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: November 16, 2016
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionSweden: Regional Ethical Review BoardNetherlands: Medical Ethics Review Committee (METC)United Kingdom: Research Ethics CommitteeBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 31 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Device:
• Parietex Progrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
• Low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Germany	Klinikum Bremen-Mitte	Bremen
Germany	Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik	Fulda
Netherlands	Catharina-ziekenhuis	Eindhoven
Sweden	Medical Center Linköping	Linköping
Sweden	Centre of clinical research	Västeras-
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Imperial College London / Faculty of Medecine	London
United Kingdom	Derriford Hospital	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)	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.	M3, M12 after surgery	No
Primary	Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)	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).	M3, M12 after surgery	No
Secondary	Foreign Body Sensation	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.	M1, M3, M12 months after surgery	No
Secondary	Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score	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 months after surgery	No
Secondary	Wound Complications and Hernia Recurrences		M12 after surgery	Yes
Secondary	Return to Work and to Normal Daily Activities		Effective date	No
Secondary	Other Post-operative Complications		M12 after surgery	No