Surgical Repair Versus Expectant Management of Occult Inguinal Hernias: Strengthening the Evidence Base and Developing a Decision Tool
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Patient threshold value for need for future surgery in order to accept Expectant Management (EM) of an Occult Inguinal Hernia (OIH) determined using standard gamble technique
研究概览
简要总结
Inguinal hernias are a common surgical problem. Best management of occult inguinal hernias, defined as hernias unable to be felt on physical exam, is unknown. From prior studies we know that most inguinal hernias will eventually become symptomatic and require surgery (70%). However, doing a repair on a very small, occult hernia may open the patient up to surgical complications, like chronic pain, earlier than necessary. This will be a multi-center randomized controlled trial of surgical repair versus expectant management of occult inguinal hernias. Patients undergoing laparoscopic unilateral inguinal hernia repair will be included. At the time of surgery, the surgeon will determine if there is an occult hernia contralateral side. If present, patients will be randomized to repair of the occult side or expectant management of the occult side. After 1 year post-operative data has been assessed, a decision tool will be created and administered to patients to aid in their decision making about treatments for their hernia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a contralateral occult inguinal hernia
排除标准
- •Patient has life expectancy of less than 2 years
- •Patients unlikely to follow-up (e.g. live out of state, unable to be reached by phone/e-mail
- •Non-English and Non-Spanish speakers
- •Pregnant or breast-feeding patients
研究组 & 干预措施
Surgery
Occult hernia found will be repaired at the same time as the initial inguinal hernia
干预措施: Occcult hernia repair (Procedure)
Expectant Management
No surgery will be done if an occult hernia is found during the initial inguinal hernia surgery
结局指标
主要结局
Patient threshold value for need for future surgery in order to accept Expectant Management (EM) of an Occult Inguinal Hernia (OIH) determined using standard gamble technique
时间窗: From Baseline up to 2 years post-operative
Assessed by using a decision tool (standard gamble method) that will be developed using information gathered at 1 year post-operative
次要结局
- Hernia recurrence(2 years post-operative)
- Operative re-intervention(1 years post-operative)
- Number of patients who develop any surgical complication(30 days post-operative)
- Assessment of chronic pain(1 year post-operative)
- Progression of hernia signs or symptoms(1 year post-operative)
- Change in Abdominal wall quality of life (AW-QOL)(From Baseline up to 2 years post-operative)
- Number of patients with an occult inguinal hernia(Time of surgery)
- Time duration for surgery(Time of surgery)
- Time off work due to the hernia surgery(Baseline to 2 years post-operative)
- Groin pain on occult hernia side(1 month and 1 year post-operative)
- Satisfaction with Decision Scale(Baseline to 2 years post-operative)
- Time to resume normal activity from any hernia surgery(Baseline to 2 years post-operative)
研究者
Julie Holihan
Assistant Professor of Surgery-Clinical
The University of Texas Health Science Center, Houston