Overview

This trial has been completed.

Condition hernia, inguinal
Treatments parietex progrip, low weight polypropylene mesh
Phase phase 4
Sponsor Medtronic - MITG
Start date October 2008
End date October 2012
Trial size 603 participants
Trial identifier NCT00827944, SC 0607/1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Parietex ProGrip
parietex progrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
(Active Comparator)
Low weight polypropylene mesh
low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Primary Outcomes

Measure
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 the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
time frame: M3, M12 after surgery

Secondary Outcomes

Measure
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 after surgery
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

Eligibility Criteria

Male participants from 31 years up to 74 years old.

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

Additional Information

Official title ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Medtronic - MITG.