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Patient-reported Outcomes for Patients Undergoing Surgery at Shouldice Hospital.

NCT06039800 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2023-09-15

No results posted yet for this study

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.

Conditions

  • Hernia

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Shouldice Hospital

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039800 on ClinicalTrials.gov