A Randomised Controlled Trial Comparing Total Extra-Peritoneal (TEP) to Lichtenstein Inguinal Hernia Repair Concerning Physical Sequelae and Quality of Life at One and Three Years - the TEPLICH Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).
研究概览
简要总结
The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery.
Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.
详细描述
Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively.
Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.
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
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men between 30-75 years of age
- •ASA class I-II
- •primary unilateral inguinal hernia
排除标准
- •lower midline incision below linea arcuate
- •large scrotal hernia
- •previously or current abuse,mental disease
- •obesity BMI > 35
- •another simultaneous operation
- •nonreducible hernia
- •severe pain in the groin without nonrelated to hernia
- •contraindications to general anesthesia
- •need of language translator
- •liver cirrhosis or ascites
- •spread cancer disease
- •previously irradiation in the area
- •lack of operations indication
研究组 & 干预措施
Lichtenstein
Open operation with onlay light weight polypropylene mesh
干预措施: Total Extraperitoneal repair (TEP) (Procedure)
Total Extraperitoneal repair (TEP)
Laparoscopic operation with preperitoneal nonfixated mesh
干预措施: Lichtenstein (Procedure)
结局指标
主要结局
Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).
时间窗: One year
The worst pain last week one year postoperatively. Measured using question 2 of IPQ-questionaire with the cutoff for pain set between grade 2 (pain present but could easily be ignored) and grade 3 (pain present but does not interfere with everyday activities)
次要结局
- Physical function score measuring the ability to perform common daily activities(The functional score was measured preoperatively, at one and three years)
- Clinical exam assessing groin complaints(Exams were performed preoperatively, at one and three years)
- Number patients with a harmful event during surgery after TEP and Lichtenstein(After one and three years)
- Quality of life measured using the SF-36 questionnaire(one and three years)
- Chronic pain right now and during the last week (IPQ1 and IPQ2) measured using question 1 and 2 of the inguinal pain questionnaire.(IPQ1 grade 2-7, IPQ1 grade 3-7 and IPQ2 grade 2-7 measured at one and three years. IPQ2 grad 3-7 measured at three years.)
- Number of patients with a recurrence after TEP and Lichtenstein surgery(After one and three years)
- A newly developed SexIHS questionnaire designed to specifically address sexual dysfunction associated with a diagnosed inguinal hernia or following inguinal hernia surgery.(Mean 33 months after surgery)
- Number of patients with a adverse events after TEP and Lichtenstein surgery(After one and three years)
研究者
Agneta Montgomery
Assosiate professor
Skane University Hospital