A Register-based Randomized Controlled Multicenter Trial of Laparo-endoscopic Bilateral Inguinal Hernia Repairs With an Asymptomatic Contralateral Hernia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Patient-reported Chronic pain 1 year after surgery via PROM
研究概览
简要总结
Groin hernia repair is one of the most common surgical procedures, with around 20 million performed annually worldwide. In Sweden, over 16,000 groin hernia operations are registered each year in the Swedish Hernia Register (SHR), which has maintained 98% data completeness and validation over the past 30 years. The SHR, with currently over 400,000 recorded operations, has significantly improved the quality of hernia surgery both in Sweden and internationally. Two key outcomes that can affect a patient's quality of life after groin hernia repair are recurrence and chronic pain, both of which are tracked by the SHR and serve as quality indicators for hernia surgery in Sweden. The management of asymptomatic contralateral inguinal hernias in patients with bilateral hernias has been a topic of debate in recent decades. Most bilateral hernias are now treated laparoscopically, and this trend is growing. However, despite the prevalence of bilateral and asymptomatic contralateral hernias, there is no consensus on the optimal timing for repairing the asymptomatic side. This multicenter, register-based randomized controlled trial, using the highly validated Swedish Hernia Register, aims to investigate outcomes for asymptomatic contralateral inguinal hernias in patients with bilateral hernias.Investigate the differences in the outcome of chronic pain (patient reported outcome measure with pain questionnaire), reoperation, peri - and postoperative complications and patient satisfaction between laparo-endoscopic bilateral inguinal hernia repair with an asymptomatic contralateral groin hernia versus a laparo-endoscopic unilateral inguinal hernia repair without repairing the asymptomatic contralateral groin hernia in bilateral inguinal hernias in adults. Additionally, to study the prevalence of future elective and emergency hernia repair of the unrepaired asymptomatic contralateral inguinal hernia.The chronic pain, reoperation, peri - and postoperative complications and patient satisfaction is hypothesized to be equal between bilateral inguinal hernia repairs with an asymptomatic contralateral inguinal hernia compared to unilateral symptomatic inguinal hernia repairs
详细描述
BACKGROUND
Groin hernia repair is one of the most common surgical procedures with approximately 20 million repairs performed annually in the world. In Sweden, over 18.000 groin hernia operations are prospectively registered annually in the Swedish Hernia Register (SHR). Over the past 30 years, the SHR has achieved a national completeness and data validation level of 98%. By creating a database of over 400.000 operations, the SHR has had a large impact on improving the quality of hernia surgery in Sweden as well as internationally.
There are mainly two important outcomes following a groin hernia repair that could impair the patient's quality of life; recurrence and chronic pain - both of them retained from the SHR and being main quality predictors for groin hernia repair in Sweden.
The prevalence of bilateral groin hernias has been reported up to 22%, while the prevalence of an asymptomatic contralateral groin hernia in patients with symptomatic unilateral groin hernia has been estimated to around 15%. Around 30% of all asymptomatic groin hernias are predicted to become symptomatic and require a future repair.
Chronic pain following groin hernia repair has been described to have a rate somewhere in the range of 10-15 % after a groin hernia repair. However, some studies have reported disturbing incidences up to 30-60 %, confirming that chronic pain is an unfortunate problem that impairs patients' quality of life.
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
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective laparo-endoscopic surgery of bilateral primary inguinal hernia
- •Both men and women
- •above and 18 years old
- •One of the hernias is asymptomatic
- •Surgical center that perform > 50 laparo-endoscopic groin hernia repairs per year.
排除标准
- •Recurrent groin hernias (earlier repair in the groin)
- •Femoral hernias (both symptomatic and asymptomatic)
- •Combined femoral groin hernias
- •Detected femoral hernia during surgery (they will be recommended to be operated with a bilateral repair)
- •Another operative procedure at the same time
- •A history of open lower abdominal surgery (except appendectomy) like prostate surgery
- •ASA fitness grade > 3
- •Patients that cannot undergo general anesthesia
- •Pregnancy
- •Age < 18 years
- •Infected wounds
- •Emergency operation (incarcerated hernia)
- •Inability to fill in questionnaires due to language barriers or condition as Alzheimer's
结局指标
主要结局
Patient-reported Chronic pain 1 year after surgery via PROM
时间窗: 1 year after surgery
To compare chronic pain 1 year after surgery between laparo-endoscopic bilateral inguinal hernia repair with an asymptomatic contralateral inguinal hernia vs a laparoscopic unilateral inguinal hernia repair without repairing the asymptomatic contralateral inguinal hernia in bilateral groin hernias in adults.This will be assessed via PROM - a questionnaire with item2 from the Inguinal Pain Questionnaire; Estimate the worst pain you felt in the operated groin during this past week. 1. No pain 2. Pain that could easily be ignored 3. Pain that could not be ignored but did not influence daily activities 4. Pain that could not be ignored, which affected concentration and performance of daily activities 5. Pain that inhibited most daily activities 6. Pain that required rest or bed rest 7. Pain so severe that you were forced to seek medical attention Chronic pain will be analysed as a binary outcome where scores on scale 1-3 = No pain and scores 4-7 = Pain
次要结局
- Risk of reoperation due to recurrence of the hernia repair(2, 5 and 10 years after surgery)
- Perioperative complications (safety)(Intraoperatively during surgery)
- Postoperative complications (safety)(30 days after surgery)
- Rate of future elective hernia repair of the unrepaired asymptomatic contralateral inguinal hernia(1, 2, 5 and 10 years after surgery)
- Rate of future emergency hernia repair of the unrepaired asymptomatic contralateral inguinal hernia(within 2 years after surgery)
- Rate and characteristics of found femoral hernias in the total study population(Intraoperatively during surgery)
- Operation time of surgery(Intraoperativley during surgery)
- Patient-reported satisfaction 1 year after surgery via PROM(1 year after surgery)
研究者
Maria Melkemichel
MD, PhD, General surgeon, Karolinska University Hospital, Sweden
Karolinska Institutet