Recruiting

Observational Study

Sponsor:

Shouldice Hospital

Code:

NCT06037304

Conditions

Hernia, Inguinal

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

no intervention

Study Details

Brief 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

Study ID

NCT06037304

Start date

Aug 1, 2023

Status verified date

Sep, 2023

Completion date

Aug 10, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The study population will focus on male and female patients aged 16-90 years of age, standard age of patients accepted for surgery at Shouldice Hospital, who had a Shouldice repair of a primary unilateral inguinal hernia at Shouldice Hospital, all nationalities and races, capable of speaking and reading English, in good general health, and there is no geographic location constraint. As there are no translators nor non-English survey options provided, participants who cannot complete the survey in English are excluded.

Exclusion Criteria:

Patients will be excluded if they underwent a mesh repair, a hernia that was not an inguinal type, a concurrent hernia, bilateral hernia repair, and surgery was deemed an emergency.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

no intervention

no intervention

Primary outcome measure

  • EQ5D3L one week after surgery [ Time Frame: one week after surgery ]

Central Contacts and Locations

Central contacts

Locations

Christoph Paasch

Recruiting

Thornhill, Ontario, Canada, L3T 4A3

Contacts

More Information

Sponsor

Shouldice Hospital

Last update posted

Sep 14, 2023

Last verified

Sep, 2023

Keywords

  • Quality of life
  • shouldice repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shouldice Hospital on 2023-09-14.