NCT06039800 Patient-reported Outcomes for Patients Undergoing Surgery at Shouldice Hospital.
| NCT ID | NCT06039800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shouldice Hospital |
| Condition | Hernia |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2023-08-01 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible. Exclusion Criteria: * Lack of an email address.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06039800 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06039800 currently recruiting?
Yes, NCT06039800 is actively recruiting participants. Contact the research team at cpaasch@shouldice.com for enrollment information.
Where is the NCT06039800 trial being conducted?
This trial is being conducted at Thornhill, Canada.
Who is sponsoring the NCT06039800 clinical trial?
NCT06039800 is sponsored by Shouldice Hospital. The trial plans to enroll 2,000 participants.