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Quality of Life After Shouldice Repair

NCT06037304 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-09-14

No results posted yet for this study

Summary

This research project aims to assess the quality of life (QOL) and pain/discomfort experienced by patients who have undergone primary inguinal hernia repair at Shouldice Hospital. Historically, postoperative mortality and symptom improvement have been the main outcomes assessed after hernia surgery, neglecting the patient experience. As QOL gains significance in hernia patient care, this study focuses on evaluating patient QOL before and after surgery, contributing to a better understanding of hernia surgery outcomes.

Study Objectives:

Determine preoperative quality of life. Determine patient-reported quality of life at 1 week after surgery. Determine patient-reported quality of life at 1 month after surgery. Determine patient-reported quality of life at 6 months after surgery. Evaluate changes in quality of life from the preoperative time to 6 months after surgery.

Hypotheses/Research Questions:

Does quality of life change after hernia surgery? What is the quality of life before and after primary unilateral inguinal hernia repair? Does hernia repair improve patient quality of life?

Study Design:

This is a prospective cohort pilot study involving primary unilateral inguinal hernia patients who received Shouldice repair at Shouldice Hospital. It includes chart reviews (medical histories and operative notes) and surveys at preoperative, 1-week, 1-month, and 6-month postoperative time points. Surveys are conducted using the EQ5D3L tool to measure health-related quality of life.

Study Population:

The study population includes male and female patients aged 16-90, of all nationalities and races, capable of English communication, in good general health, who had primary unilateral inguinal hernia repair at Shouldice Hospital. Exclusions encompass patients who had mesh repair, non-inguinal hernias, concurrent hernias, bilateral hernia repair, or emergency surgeries.

Data Collection:

Data is collected from patient survey responses, medical records, and charts. Surveys are administered via email at specific time points. A deferred consent process is used, and participants are informed about their rights and the ability to withdraw. Data is deidentified for privacy.

Duration of Study:

The study is expected to take 14 months, with a 3-month recruitment phase, a 6-month follow-up period, and 5 months for data analysis and write-up. The estimated participation time for each participant is 13 minutes, and no reminders are sent.

Risks and Benefits:

There are no known risks to participants, and no direct benefits are provided. Personal data is protected, and participation is voluntary.

This study aims to contribute valuable insights into the quality of life of hernia surgery patients, particularly those who have undergone open tissue hernia repair at Shouldice Hospital.

Conditions

  • Hernia, Inguinal

Interventions

OTHER

no intervention

no intervention

Sponsors & Collaborators

  • Shouldice Hospital

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-08-01
Completion
2024-08-10

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 NCT06037304 on ClinicalTrials.gov