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临床试验/NCT00451893
NCT00451893已完成不适用

An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia

Umeå University4 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2006年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
412
试验地点
4
主要终点
Pain

研究概览

简要总结

The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes.

Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

详细描述

The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. Furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). Chronic pain is defined as pain that remains 3 months after the operation. Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery.

In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Male, age 25 years or older
  • Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before

排除标准

  • The patient is not able or do not want to give written informed consent
  • The patient is not suitable for an operation in local anesthesia
  • Anticoagulant medication or a known coagulation disorder

研究组 & 干预措施

Heavy-weight

Active Comparator

Lichtenstein operation performed with a heavy-weight mesh.

干预措施: Lichtenstein operation with a heavy-weight mesh (Procedure)

Light-weight

Active Comparator

Lichtenstein operation performed with a light-weight mesh.

干预措施: Lichtenstein operation with a light-weight mesh (Procedure)

结局指标

主要结局

Pain

时间窗: Two, seven and eleven postoperative days. Four months and one year after the operation.

Health-related Quality of Life

时间窗: Two, seven and eleven postoperative days. Four months and one year after the operation.

Postoperative pain measured with pain assessment scale

时间窗: Four months after the operation.

McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.

Postoperative pain measured with pain assessment scale

时间窗: One year after the operation.

McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.

Health-related Quality of Life measured with EQ-5D index

时间窗: One year after the operation.

The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.

Postoperative pain measured with pain assessment scale for inguinal pain

时间窗: 10 years

Inguinal Pain Questionnaire for assessing impact on daily activities. The short form of Inguinal Pain Questionnaire has 7 grades (1-7). Increasing grade means more pain. Grade 1 represents no pain.

次要结局

  • Recurrences(Four months and one year after the operation.)
  • Health-care costs(Four months and one year after the operation.)
  • Postoperative complications(Four months and one year after the operation.)
  • Sick leave(Four months and one year after the operation.)
  • Health related quality of life measured with EQ-5D index(2 days after the operation)
  • Health related quality of life measured with EQ-5D index(Seven days after the operation.)
  • Health related quality of life measured with EQ-5D index(Eleven days after the operation.)
  • Health related quality of life measured with EQ-5D index(Four months after the operation)
  • Postoperative complications(Within one year after the operation.)
  • Recurrences(Within one year after the operation.)
  • Health-care costs(Within one year after the operation.)
  • Sick leave(Within one year after the operation.)

研究者

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

Markku Haapamaki

Associate professor, MD, PhD

Umeå University

研究点 (4)

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