Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06037304 |
| Other study ID # |
QoL |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
August 10, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Shouldice Hospital |
| Contact |
Christoph Paasch, MD |
| Phone |
9058891125 |
| Email |
cpaasch[@]shouldice.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The proposed project is a pilot study designed in a prospective cohort manner, on primary
unilateral inguinal hernia patients who had a Shouldice repair at the Shouldice Hospital. It
includes prospective chart review (medical histories and operative notes) and a qualitative
component (surveys). Patients will be emailed 5-7 days before surgery, with information
inviting them to participate or read more about this research project, and a link to a full
consent form. If patients consent they will be taken directly to the first (preoperative)
survey and the same methodology will be used again at 1 week, 1 month, and 6 months after
surgery. Contact is made by email using the hospital's current survey site: Simple Survey.
The survey is made up of the EQ5D3L, which is a standardized measurement of QOL (health
related). The EQ5D3L contains two parts, one that measures health status through rating 5
questions in terms of having no, some or extreme problems with mobility, self-care, usual
activities, pain/discomfort, and anxiety/depression.
The second part contains a visual analogue scale called EQVAS where participants rate their
overall health from 0- worst imaginable to 100- best imaginable. The choice to use the EQ5D3L
was made because it is a commonly used tool, has shown comparable results to other validated
surveys like the CCS [6], and the EQ5D3L is a single short way to measure QOL. Although many
studies use multiple surveys to assess QOL, for simplicity sake, and to reduce time burden on
patients as well as prevent any reduced response rate just the EQ5D3L will be used.
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. 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.
We aim to contact 1000 2400 patients to analyze a total of 400 participants. This is based
off information gathered by the researchers from the first six weeks of recruitment for this
project. this institution from previously done prospective projects. When consent forms were
emailed, there was a response rate of 4530%, with a retention of patients meeting the
criteria and being sent the follow up surveys at 18%. No dropout rate has been
measured/considered as we will gather data for this pilot project to go on with a sample size
calculation in the future. The 400 patients were concluded based off a multicenter study that
used the EQ5D3L and had similar objectives as this present study. The 2018 study looked at
survey responses after Lichtenstein repair with two difference meshes and had sample sizes of
411 and 397. Thus, analyzing 400 patients would allow for a meaningful comparison to open
inguinal hernia repair.
