Hernia, InguinalQoLNCT06037304
Quality of Life After Shouldice Repair
An observational study of Hernia, Inguinal, run by Shouldice Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Hernia, Inguinal
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 10 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Christoph Paasch
Thornhill, Ontario, L3T 4A3
Christoph Paasch, 9058891125 ext. 435, cpaasch@shouldice.com
About this study
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:
Read more
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.
Read the detailed 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.
- Conditions
- Hernia, Inguinal
- Being tested
- no intervention
- Keywords
- Quality of life, shouldice repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D3L one week after surgery
Measured: one week after surgery
Secondary outcomes (2)
EQ5D3L one month after surgery
Measured: one month after surgery
EQ5D3L six months after surgery
Measured: ix months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shouldice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037304
- Sponsor's protocol ID
- QoL
- Acronym
- QoL
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Shouldice Repair
- ClinicalTrials.gov ID
- NCT06037304
- Acronym / sponsor ID
- QoL / QoL
- Conditions
- Hernia, Inguinal
- Keywords
- Quality of life, shouldice repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shouldice HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
EQ5D3L one week after surgery
Time frame: one week after surgery
2 secondary outcomes
EQ5D3L one month after surgery
Time frame: one month after surgery
EQ5D3L six months after surgery
Time frame: ix months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal, run by Shouldice Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Paasch, MD (9058891125 ext. 435, cpaasch@shouldice.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ5D3L one week after surgery (time frame: one week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.