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临床试验/NCT01830452
NCT01830452Unknown4 期

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.

Groene Hart Ziekenhuis4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
4 期
入组人数
400
试验地点
4
主要终点
Incidence of chronic post-operative inguinal pain

研究概览

简要总结

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.

详细描述

INTRODUCTION

In 1984 Lichtenstein popularized routine use of a heavy weight polypropylene mesh fixed with non-absorbable sutures to create a tension-free hernioplasty. This technique became the gold standard in many clinics due to its low rate of recurrence and direct post-operative pain6. Focus has now shifted to the occurrence of chronic pain and neuralgia after Lichtenstein hernioplasty. Chronic post-operative pain has been defined as pain lasting more than 3 months after surgery. The surgical repair technique seems to be an important etiologic factor in this. This includes aspects like type of mesh used, manner of fixation of the prosthetic material and handling of the cutaneous nerves.

The aim of this study is to investigate differences in incidence of chronic post-operative pain between the two types of fixation for the same mesh. The mesh used is ligthweight and made of polyester. The mesh will be fixated by either non-adsorbable sutures, according to Lichtenstein, or by small microhooks on the lower surface of the mesh (Parietex Progrip Mesh, Covidien).

Rationale for the Parietex Progrip Mesh

To reduce post-operative chronic pain it is thought being important to use low weight large pore size oligofilament meshes fixed with a minimal use of devices or no devices at all. This both to minimize compression/entrapment neuropathy and inflammation. The Parietex Progrip mesh biocompatibility is enhanced using low-weight monofilament isoelastic polyester with large pores. The hydrophilic characteristics of polyester are known to cause less shrinkage and fibrotic tissue formation than the more standard polypropylene.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Incidence of chronic post-operative inguinal pain

时间窗: 12 months

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

次要结局

  • Recurrence rate(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marijke Molegraaf

MD

Groene Hart Ziekenhuis

研究点 (4)

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