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

NCT06039800 | Recruiting

• 1 other identifier: ShouldiceH
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

hernia; groin hernia

Outcome Measures

Primary Outcomes (1)

• Recurrence after hernia repair

  Recurrence after hernia repair

  Recurrence after hernia repair after one year

Secondary Outcomes (3)

• Recurrence after hernia repair

  Recurrence after hernia repair after three years

• Recurrence after hernia repair

  Recurrence after hernia repair after five years

• Recurrence after hernia repair

  Recurrence after hernia repair after 30 days

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients aged 16-90 who underwent hernia surgery at Shouldice Hospital, with the only exclusion being those without an email address. This exclusion is due to the electronic nature of the project. Since this is the first study of its kind at Shouldice Hospital, the required sample size is unknown, and this project serves as a pilot for systematic follow-up on patient and surgical outcomes. For the specific analysis of infection rates, the study aims to gather data from 2,000 patients. To achieve this, the researchers plan to contact 4,500 patients, based on information from previous projects. Initial research contact yielded a 45% response rate, and no dropout rate has been measured yet, as data collection for this study will inform future sample size calculations.

You may qualify if:

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

You may not qualify if:

• Lack of an email address.

Sponsors & Collaborators

• Shouldice Hospital: lead

Study Sites (1)

Shouldice Hospital

Thornhill, Ontario, L3T 4A3,, Canada

RECRUITING

MeSH Terms

Conditions

Hernia; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal

Central Study Contacts

Christoph Paasch, MD

CONTACT

6476542790; cpaasch@shouldice.com

Marguerite Mainprize, MSc

CONTACT

4169316244; mmainprize@shouldice.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)