Quality of Life After Shouldice Repair

NCT06037304 | Unknown

• 1 other identifier: QoL
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

Quality of life; shouldice repair

Outcome Measures

Primary Outcomes (1)

• EQ5D3L one week after surgery

  one week after surgery

Secondary Outcomes (2)

• EQ5D3L one month after surgery

  one month after surgery

• EQ5D3L six months after surgery

  ix months after surgery

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study focuses on patients aged 16-90 years who underwent a primary unilateral inguinal hernia repair at Shouldice Hospital. The inclusion criteria encompass both male and female patients of all nationalities and races, capable of communicating in English, in good general health, and who did not undergo emergency surgery. Patients who had mesh repair, hernias other than inguinal, concurrent hernias, bilateral hernia repairs, and those who couldn't complete surveys in English are excluded. The goal is to contact 2,400 patients to ultimately analyze 400 participants, based on recruitment data. Consent forms yielded a 45-30% response rate, with an 18% follow-up survey retention rate. No dropout rate has been measured yet. The choice of 400 patients is based on a similar study that analyzed sample sizes of 411 and 397 in a multicenter study involving Lichtenstein repair with different meshes for meaningful comparison to open inguinal hernia repair.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shouldice Hospital: lead

Study Sites (1)

Christoph Paasch

Thornhill, Ontario, L3T 4A3, Canada

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christoph Paasch, MD

CONTACT

9058891125; cpaasch@shouldice.com

Marguerite Mainprize

CONTACT

9058891125; 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 7, 2023
• First Posted: September 14, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 10, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)