NCT00827944

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
603

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

November 17, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

4 years

First QC Date

January 22, 2009

Results QC Date

August 23, 2013

Last Update Submit

November 16, 2016

Conditions

Hernia, Inguinal

Keywords

Uncomplicated primary inguinal hernias

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • Foreign Body Sensation

    M1, M3, M12 months after surgery

  • Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score

    3 months after surgery

  • Wound Complications and Hernia Recurrences

    M12 after surgery

  • Return to Work and to Normal Daily Activities

    Effective date

  • Other Post-operative Complications

    M12 after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Parietex ProGrip

Device: Parietex Progrip

2

ACTIVE COMPARATOR

Low weight polypropylene mesh

Device: Low weight polypropylene mesh

Interventions

Parietex ProgripDEVICE

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

1
Low weight polypropylene meshDEVICE

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

2

Eligibility Criteria

Age31 Years - 74 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All male patients at participating centers with a primary, uncomplicated inguinal hernia.
  • Collar of the defect ≤ 4 cm
  • Signed informed consent

You may not qualify if:

  • years ≥ Age ≥ 75 years
  • Emergency procedure
  • Bilateral inguinal hernia
  • Recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Klinikum Bremen-Mitte

Bremen, 28177, Germany

Location

Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik

Fulda, D- 36039 Fulda, Germany

Location

Catharina-ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Medical Center Linköping

Linköping, 582 24, Sweden

Location

Centre of clinical research

Västeras-, 721 89, Sweden

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Imperial College London / Faculty of Medecine

London, W2 1NY, United Kingdom

Location

Derriford Hospital

Plymouth, PL6, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25146918DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pr. Andrew KINGSNORTH
Organization
Derriford Hospital, Department of Surgery
Andrew.Kingsnorth@phnt.swest.nhs.uk
+44 175 276 3017

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 17, 2016

Results First Posted

November 17, 2016

Record last verified: 2016-11

Locations

BE(1)DE(2)SE(2)GB(3)NL(1)