Patient Reported Outcome Measures (PROMS): Follow up of Shouldice Hospital Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Recurrence after hernia repair
研究概览
简要总结
Background:
Previous publications have highlighted limited data on patient outcomes and experiences at Shouldice Hospital. Existing studies from Europe reported outcomes following Shouldice repair but lacked recent data. The current project seeks to optimize patient care and knowledge through systematic follow-up.
Study Objectives:
Establish a patient-reported outcome measure follow-up program. Evaluate postoperative complication rates. Determine important outcomes to patients. Establish and monitor patient satisfaction with decision-making and hernia repair.
Hypotheses/Research Questions:
Several research questions related to patient motivations, outcomes, knowledge, and satisfaction are posed for investigation.
Potential Risks and Benefits:
No anticipated risks to participants. Participants won't directly benefit but contribute to improving patient care and knowledge.
Study Design:
The study employs a prospective follow-up approach. Surveys are sent at specific intervals (30-40 days, 1-year, 3-years, and 5-years) via email.
Consent forms are included in the email, allowing participants to choose their level of involvement. Data is collected from survey responses, patient charts, and operative notes.
Study Population:
All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.
Exclusion criteria:
Lack of an email address. The required sample size is unknown, and this study serves as a pilot.
Data Collection:
Data is collected from surveys, patient charts, and operative notes. Consent is obtained through deferred consent (initial contact via email, with consent forms provided).
Safeguards are in place to protect personal health information.
Duration of Study:
Estimated to take 5-6 years. Recruitment/enrollment: 6-12 months. Follow-up: 5 years from the last enrolled participant. Data analysis and write-up: 5 months.
Overlap with Other Projects:
Concerns about overlap with other studies are addressed, and concurrent participation is allowed. Participants can withdraw at any time.
In summary, this research project aims to gather comprehensive data on hernia surgery outcomes, patient experiences, and satisfaction at Shouldice Hospital through a systematic follow-up approach, contributing to the improvement of patient care and knowledge in this field.
详细描述
Increasing awareness, research, and publications on patient reported outcomes, patient knowledge, and what matters to patients are being done. There is limited data available in these areas at Shouldice Hospital, leaving potential gaps in knowledge and areas of improvement unidentified. Large scale follow-up on the Shouldice Hospital's postoperative complications.
There are two publications within the last 18 years from Europe reporting outcomes following Shouldice repair with a larger number of enrolled individuals. These publications included 3,888 Shouldice repairs. Bittner et al. (2005) published a Meta-analysis analyzing the postoperative outcome following TAPP/TEP (n=1,830) and Shouldice repair (n=1,773). The authors revealed an infection rate of 0.9%, a hematoma rate of 6.4% (higher than in the laparoscopic group) and a seroma rate of 1.2%. The recurrence rate was 2%. Moreover, a 5.4% rate of chronic pain and a 30-days period until return to work were published. These rates were higher in comparison to endoscopic hernia repair (Bittner et al, 2005). In addition, a German matched-pair registry analysis among 2,115 cases of Shouldice repair took place in 2018. The authors published, that for a selected group of patients (average age: 40 years, a large proportion of women of 30%, a mean BMI value of 24 kg/m2 and a proportion of defect sizes up to 3 cm of over 85%) the Shouldice repair can be used for primary unilateral inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and TAPP operations (Kockerling et al, 2018). Malik et al. (2016) provided information on the recurrence rate (age-standardized recurrence risk of 1.15%; n=65,148) of patients who were operated on in the Shouldice repair at the Shouldice hospital. But in terms of SSI, SSO and postoperative outcome in general no current information from our Shouldice hospital has been revealed within the last two decades (Malik et al, 2016).
In order to further optimize, evaluate, and increase knowledge of the Shouldice repair systematic follow-up of patients who were operated on at the Shouldice Hospital should be updated. The current project aims to perform a systematic follow-up of patients for the purpose of supporting the ongoing improvement of patient care and knowledge. This study will act as a pilot for refining our long term follow up, focused on patient and surgical outcomes.
Study Objectives:
- Establish a patient reported outcome measure follow up program at Shouldice Hospital
- Evaluate the postoperative complication rate (pain, infection, recurrence, and other complications)
- Determine the reasoning and important outcomes to patients who undergo hernia repair at Shouldice Hospital.
- Establish and monitor patient satisfaction with decision making and hernia repair.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.
排除标准
- •Lack of an email address.
结局指标
主要结局
Recurrence after hernia repair
时间窗: Recurrence after hernia repair after one year
Recurrence after hernia repair
次要结局
- Recurrence after hernia repair(Recurrence after hernia repair after 30 days)