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

NCT01830452 | Unknown Phase 4

• 1 other identifier: NL27506.058.09
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hernia, Inguinal; Unilateral Inguinal Hernia

Keywords

Chronic pain; Progrip Mesh; Self gripping mesh; Lichtenstein

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic post-operative inguinal pain

  The definition of chronic pain given by the IASP will be used.

  12 months

Secondary Outcomes (1)

• Recurrence rate

  12 months

Other Outcomes (4)

• per- and post operative complications

  3 months

• Operating time

  Day of surgery

• Quality of life

  12 months

Study Arms (2)

Parietex Progrip mesh

EXPERIMENTAL

Ventral hernioplasty using a (self gripping / self adhering / self fixating) Progrip mesh not needing fixation devices

Procedure: Self-fixating Parietex Progrip Mesh

Parietex Mesh

ACTIVE COMPARATOR

Ventral hernioplasty using a polyester mesh fixed with non absorbable sutures as described by Lichtenstein/Amid

Procedure: Self-fixating Parietex Progrip Mesh

Interventions

Self-fixating Parietex Progrip Mesh PROCEDURE

Lichtenstein hernioplasty using a self fixating Parietex Progrip mesh not needing any fixating devices

Also known as: Open hernioplasty, Inguinal hernioplasty, Anterior hernioplasty

Parietex Mesh; Parietex Progrip mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concurrent femoral hernia
• Incarcerated or strangulated inguinal hernia
• ASA 4 or ASA 5
• Impaired adequate follow up
• Participation in another trial

Sponsors & Collaborators

• Groene Hart Ziekenhuis: lead
• Erasmus Medical Center: collaborator

Study Sites (2)

Groene Hart Ziekenhuis

Gouda, 2800BB, Netherlands

RECRUITING

Sint Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

RECRUITING

Related Publications (1)

• Molegraaf MJ, Grotenhuis B, Torensma B, de Ridder V, Lange JF, Swank DJ. The HIPPO Trial, a Randomized Double-blind Trial Comparing Self-gripping Parietex Progrip Mesh and Sutured Parietex Mesh in Lichtenstein Hernioplasty: A Long-term Follow-up Study. Ann Surg. 2017 Dec;266(6):939-945. doi: 10.1097/SLA.0000000000002169.

  PMID: 28257318 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Chronic Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Johan F Lange, Prof

  Erasmus Medical Center

  STUDY DIRECTOR

Central Study Contacts

Marijke J Molegraaf, MD

CONTACT

0640371747; mjmolegraaf@gmail.com

Marijn Takkenberg, MD

CONTACT

0180-505050; marijntakkenberg@ghz.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: April 12, 2013
• Study Start: September 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

NL (2)