WATCH IT TRIAL WAtchful Waiting Versus immediaTe Repair for Occult Contralateral Hernias Found During MIS Inguinal Hernia Repair Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- 30-day (±15) post-operative quality of life
研究概览
简要总结
This study will compare two ways of managing a small, hidden hernia that can sometimes be found during minimally invasive surgery to repair a hernia on one side of the groin. Occasionally while fixing the known hernia, the surgeon discovers a small hernia on the other side that has not caused any symptoms. Surgeons do not agree on the best way to handle these hernias. Some believe it should be repaired right away during the same operation to prevent it from getting bigger or from causing symptoms later, which could require another surgery. Others believe it is better to leave it alone since it is not causing problems and groin hernia surgery carries risks including long-term pain.
This study will randomly assign patients, if a hidden hernia is found during surgery, to either having it repaired immediately or to have it monitored over time. Patients will be followed up at 30 days, 1 year and 2 years following surgery. The researchers will compare recovery and quality of life between the two groups. For those in the monitoring group, the study will also track whether the hidden hernia causes symptoms or eventually needs surgery. The goal is to determine whether repairing the hidden hernia right away is as safe and effective as watching and waiting, so doctors and patients can make more informed decisions in the future.
详细描述
This is a multicenter randomized controlled trial evaluating two management strategies - watchful waiting versus immediate repair - for occult contralateral inguinal hernias discovered during minimally invasive unilateral inguinal hernia repair. The management of occult inguinal hernias discovered at the time of laparoscopic inguinal hernia repair remains controversial. Many surgeons advocate for immediate repair during the index operation as this prevents reoperation as patients risk hernia progression and developing symptoms in the future. Others refrain from repair given that this occult hernia is asymptomatic and does not justify the risk of complications, including chronic pain, associated with repair. Currently there is no level 1 evidence to guide decision making for immediate repair versus watchful waiting. We plan to conduct at randomized, multi-center, non-inferiority trial to establish if immediate repair is non-inferior to watchful waiting in short term 30-day quality of life. Patients will be randomized intraoperatively once an occult contralateral inguinal hernia is identified. Patients will be followed up at 30-day, 1 and 2 years. In the watchful waiting group, occult hernia-related complications and those requiring repair will be captured.
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 (Participant)
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
- •Male or female patients ≥18 years old
- •Symptomatic unilateral inguinal hernia
- •Occult contralateral hernia identified intraoperatively
- •Ability to provide informed consent
排除标准
- •Prior contralateral inguinal hernia repair
- •Symptomatic, bilateral inguinal hernias confirmed on physical exam
- •Contraindications to general anesthesia or surgery
- •Urgent or emergent presentations
- •Adults unable to consent
- •Pregnant patients
研究组 & 干预措施
Immediate occult hernia repair group
Patients who are randomized to immediate occult hernia repair will undergo TAPP hernia repair with mesh of their occult inguinal hernia following repair of their symptomatic inguinal hernia.
干预措施: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines (Procedure)
Watchful waiting occult hernia group
Patients randomized to the watchful waiting group will undergo standard transabdominal preperitoneal inguinal hernia repair with mesh of their symptomatic hernia. Their occult hernia will be left alone.
干预措施: Watchful waiting with supportive care (Procedure)
结局指标
主要结局
30-day (±15) post-operative quality of life
时间窗: 30 days postoperatively
At 30 days postoperatively, patients will see their operating surgeon and will undergo a physical exam and complete a EuraHS survey as is standard of care. The EuraHS Quality of Life Score, validated for inguinal hernia patients, allows quantification of pain, physical restriction, and cosmetic satisfaction-domains directly affected by surgical intervention.
次要结局
- Rate of occult hernias that require repair as well as occult hernia related emergencies.(2 years)
- Changes in quality of life over time as measured by EuraHS at 1 year, and 2 years.(2 years)
- Difference in rate of wound complications at 30-days (±15) following surgery.(30-days)
- Evaluate differences in readmissions, medical complications, and reoperations at 30 (± 15) days, 1 and 2 years.(2 years)
- Evaluate differences in post-operative opioid prescribing and opioid consumption at 30 (± 15) days.(30 days)
- Evaluate difference in inguinal hernia recurrence at 1and 2 years following surgery.(2 years)
- Evaluate chronic groin pain at 1 and 2 years using the pain domain of the EuraHS score.(2 years)
- Perform a formal cost effectiveness analysis utilizing incremental cost effectiveness ratios.(2 years)
研究者
Megan Melland-Smith
Principal Investigator
Northwestern University