Less Chronic Pain After Lichtenstein Hernioplasty Using the Self-gripping Parietex Progrip Mesh (HIPPO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Groene Hart Ziekenhuis
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
Marijke Molegraaf, Groene Hart Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01830452
First received: February 6, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

Chronic pain after Lichtenstein hernioplasty is a common problem with an incidence of 11%. Many factors influence the onset and persistence of pain. Mesh characteristics and fixation have been pointed as important etiologic factors. This study compares two types of fixation for the same mesh. The mesh used is a lightweight parietex mesh. In the control group this mesh will be fixed with non absorbable sutures. In the study group sutures will not be needed because of self gripping microhooks on the surface of the mesh.

Methods: The HIPPO trial is a multicenter double blind randomized clinical trial. Patients will be randomly allocated to the sutured mesh or the self-gripping mesh. Hernia repair will be done according to Lichtenstein as described by Amid et all. Included will be all unilateral primary inguinal hernia in man patients aged 18 years or older not meeting the exclusion criteria. Patients will be followed for two years. The main endpoint is the amount of post-operative chronic pain evaluated by VAS scores. The existence of neuropathic pain will be evaluated by the Paindetect questionnaire (and a bedside variant of the QST). Secondary endpoints are recurrence rate, post-operative complications, costs, hospital stay, QOL, return to work and daily activities, genital and sexual problems. To demonstrate a difference in VAS score of 10 with α=0.05 and power 80% a sample size of 400 patients is calculated.

Discussion: Hypothesized is that the self gripping non-sutured mesh (Parietex Progrip) will cause less post-operative and chronic pain without enhancing the recurrence rate.


Condition Intervention Phase
Hernia, Inguinal
Unilateral Inguinal Hernia
Procedure: Self-fixating Parietex Progrip Mesh
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Randomised Controled Trial Comparing the Effect of a New Self-gripping Lightweight Polyester Mesh and a Normal Sutured Lightweight Polyester Mesh on the Incidence of Chronic Inguinodynia in Lichtenstein Hernioplasty.

Resource links provided by NLM:


Further study details as provided by Groene Hart Ziekenhuis:

Primary Outcome Measures:
  • Incidence of chronic post-operative inguinal pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The definition of chronic pain given by the IASP will be used.


Secondary Outcome Measures:
  • Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • per- and post operative complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Operating time [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parietex Progrip mesh
Ventral hernioplasty using a (self gripping / self adhering / self fixating) Progrip mesh not needing fixation devices
Procedure: Self-fixating Parietex Progrip Mesh
Lichtenstein hernioplasty using a self fixating Parietex Progrip mesh not needing any fixating devices
Other Names:
  • Open hernioplasty
  • Inguinal hernioplasty
  • Anterior hernioplasty
Active Comparator: Parietex Mesh
Ventral hernioplasty using a polyester mesh fixed with non absorbable sutures as described by Lichtenstein/Amid
Procedure: Self-fixating Parietex Progrip Mesh
Lichtenstein hernioplasty using a self fixating Parietex Progrip mesh not needing any fixating devices
Other Names:
  • Open hernioplasty
  • Inguinal hernioplasty
  • Anterior hernioplasty

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary unilateral inguinal hernia
  • Capacitated male person
  • Age ≥ 18 years

Exclusion Criteria:

  • Concurrent femoral hernia
  • Incarcerated or strangulated inguinal hernia
  • ASA 4 or ASA 5
  • Impaired adequate follow up
  • Participation in another trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830452

Contacts
Contact: Marijke J Molegraaf, MD 0640371747 ext 0031 mjmolegraaf@gmail.com
Contact: Marijn Takkenberg, MD 0180-505050 ext 0031 marijntakkenberg@ghz.nl

Locations
Netherlands
Groene Hart Ziekenhuis Recruiting
Gouda, Netherlands, 2800BB
Contact: Marijke J Molegraaf, MD    0640371747 ext 0031    mjmolegraaf@gmail.com   
Contact: Marijn Takkenberg, MD    0180-505050 ext 0031    marijntakkenberg@ghz.nl   
Principal Investigator: Marijke J Molegraaf, MD         
Sint Franciscus Gasthuis Recruiting
Rotterdam, Netherlands, 3045 PM
Contact: Brechtje Grotenhuis, Dr    010 461 6161 ext 0031    b.grotenhuis@erasmusmc.nl   
Contact: Marijke J Molegraaf, MD    0640371747 ext 0031    mjmolegraaf@gmail.com   
Principal Investigator: Brechtje Grotenhuis, Dr         
Sponsors and Collaborators
Groene Hart Ziekenhuis
Erasmus Medical Center
Investigators
Study Director: Johan F Lange, Prof Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Marijke Molegraaf, MD, Groene Hart Ziekenhuis
ClinicalTrials.gov Identifier: NCT01830452     History of Changes
Other Study ID Numbers: NL27506.058.09
Study First Received: February 6, 2013
Last Updated: April 9, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Groene Hart Ziekenhuis:
Chronic pain
Progrip Mesh
Self gripping mesh
Lichtenstein

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Chronic Pain
Pathological Conditions, Anatomical
Hernia, Abdominal
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014