Shouldice Hospital Outcome Study
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Proportion of participants with pain-related interference in multiple life domains
研究概览
简要总结
A prospective cohort study recruiting participants from the Shouldice Hospital. The study population consists of healthy patients electing to receive hernia surgery for a primary inguinal hernia on an inpatient basis. The goal of this study is to determine the incidence of hernia pain and its intensity as well as other related outcomes up to one year after primary unilateral inguinal hernia repair.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form.
- •Willing to comply with all study procedures and be available for the duration of the study (patients have fixed address, access to phone, email, internet, and/or a computer)
- •Male or female, aged 18 to 90 years.
- •Subjects having surgery on a primary unilateral inguinal hernia
- •In good general health as evidenced by medical history
- •Capable of speaking and reading English sufficiently well to complete the questionnaires
排除标准
- •Surgery is deemed an emergency procedure (any obstruction, incarceration or irreducible hernias).
- •Other abdominal hernias being operated on at the same time or surgery is planned during the follow-up period (incisional and umbilical hernias)
- •If hernia recurs within the study period and there is a reoperation within the year
- •BMI >40kg/m2
- •Patients unable to understand English, written and spoken
- •Patients with collagen or connective tissue disorders
- •Local (site of surgery) or systemic infection
- •Any known diseases that impair nerve function
- •Patients who end up getting a mesh repair during surgery
- •Impairment of cognitive function (e.g. dementia)
- •Pregnancy or lactation
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
结局指标
主要结局
Proportion of participants with pain-related interference in multiple life domains
时间窗: one-year post surgery
Brief Pain Inventory - pain interference
Proportion of participants with pain severity scores > zero at one year
时间窗: one-year post surgery
Brief Pain Inventory - pain severity 0-10 numeric rating scale. Typically score \>= 4 corresponds to moderate-to severe pain severity
Proportion of participants with neuropathic pain symptoms
时间窗: one year
ID Pain 6-items total score ranges from 0 to 6
次要结局
- Do pain preoperative and early postoperative pain catastrophizing scores predict pain incidence, severity, and/or interference(one year)
- Does pre-operative resilience scores predict lower pain incidence, severity, and/or interference(one-year)
- proportion of participants with significant symptoms of anxiety, depression(one-year post surgery)
- Do preoperative perceived stress scores predict pain incidence, severity, and/or interference(one-year)