Pain and Quality of Life After Inguinal Hernia Repair. Randomized Study Comparing Laparoscopic TAPP Repair With Open Lichtenstein Repair (QoL-TAPP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Chronic pain
研究概览
简要总结
This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia. Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score).
详细描述
Inguinal hernia repair is one of the most frequently performed surgical operations. Since the introduction of mesh repair, recurrence rates have fallen dramatically and chronic pain, as a side-effect of surgery, is becoming increasingly important.
Chronic pain is defined as pain or discomfort that lasts for more than 3 months after surgery. The reported incidence of chronic pain varies between 0 and 75 per cent after open mesh repair, and between 0 and 29 per cent after laparoscopic repair. Prospective trials suggest that there is less chronic pain after laparoscopic than open repair.
Although pain is an important parameter determining the Quality of Life (QoL) after a hernia operation, other aspects, like restriction of activities and esthetical outcome, are also of importance.
This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia.
Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score). The EuraHS-QoL score is a validated hernia specific questionnaire with 9 questions that can be scored by the patient in an 11-point scale from 0-10. The EuraHS-QoL questions are divided in 3 domains: "Pain" (range 0-30), "Restriction of activities" (range 0-40), and "Esthetical discomfort" (range 0-20). The total score ranges from 0-90, with the lower scores being the most favourable outcome.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary inguinal hernia
- •unilateral hernia
排除标准
- •bilateral hernia
- •recurrent hernia
- •incarcerated hernia
- •large scrotal hernia
- •known femoral hernia
- •need for associated procedures
- •not able to understand the questionaire
- •immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
- •chronic renal failure (hemodialysis)
- •active infection
- •pregnancy
- •allergy to polypropylene or cyanoacrylate
- •patient's refusal and/or absence of informed consent
研究组 & 干预措施
Laparoscopic repair
Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)
干预措施: Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair) (Procedure)
Open repair
Open Inguinal Hernia Repair (Lichtenstein repair)
干预措施: Open Inguinal Hernia Repair (Lichtenstein repair) (Procedure)
结局指标
主要结局
Chronic pain
时间窗: 1 year
Pain scores (0-10) using the European Registry for Abdominal Wall Hernias Quality of Life Instrument (EuraHS Quality of Life questionnaire). Each question has a scale from 0-10, whereas 0 is considered the best outcome.
次要结局
- Restrictions of activities(1 year)
- Rate of postoperative complications(30 days)
- Early recurrences(1-year)
- Cosmetic discomfort(1 year)
- Duration of surgery(Surgery)