Recruiting

Observational Study

Sponsor:

Shouldice Hospital

Code:

NCT06039800

Conditions

Hernia

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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.

Conditions

Hernia

Study ID

NCT06039800

Start date

Aug 1, 2023

Status verified date

Sep, 2023

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.

Exclusion Criteria:

  • Lack of an email address.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

No intervention

No intervention

Primary outcome measure

  • Recurrence after hernia repair [ Time Frame: Recurrence after hernia repair after one year ]

Central Contacts and Locations

Central contacts

Marguerite Mainprize, MSc

4169316244mmainprize@shouldice.com

Locations

Shouldice Hospital

Recruiting

Thornhill, Ontario, Canada, L3T 4A3,

Contacts

Principal Investigator:

Fernando Netto Spencer, PhD

More Information

Sponsor

Shouldice Hospital

Last update posted

Sep 15, 2023

Last verified

Sep, 2023

Keywords

  • hernia
  • groin hernia

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 2023-09-15.