Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06039800 |
| Other study ID # |
ShouldiceH |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
August 2028 |
Study information
| Verified date |
September 2023 |
| Source |
Shouldice Hospital |
| Contact |
Christoph Paasch, MD |
| Phone |
6476542790 |
| Email |
cpaasch[@]shouldice.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Increasing awareness, research, and publications on patient reported outcomes, patient
knowledge, and what matters to patients are being done. There is limited data available in
these areas at Shouldice Hospital, leaving potential gaps in knowledge and areas of
improvement unidentified. Large scale follow-up on the Shouldice Hospital's postoperative
complications.
There are two publications within the last 18 years from Europe reporting outcomes following
Shouldice repair with a larger number of enrolled individuals. These publications included
3,888 Shouldice repairs. Bittner et al. (2005) published a Meta-analysis analyzing the
postoperative outcome following TAPP/TEP (n=1,830) and Shouldice repair (n=1,773). The
authors revealed an infection rate of 0.9%, a hematoma rate of 6.4% (higher than in the
laparoscopic group) and a seroma rate of 1.2%. The recurrence rate was 2%. Moreover, a 5.4%
rate of chronic pain and a 30-days period until return to work were published. These rates
were higher in comparison to endoscopic hernia repair (Bittner et al, 2005). In addition, a
German matched-pair registry analysis among 2,115 cases of Shouldice repair took place in
2018. The authors published, that for a selected group of patients (average age: 40 years, a
large proportion of women of 30%, a mean BMI value of 24 kg/m2 and a proportion of defect
sizes up to 3 cm of over 85%) the Shouldice repair can be used for primary unilateral
inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and
TAPP operations (Kockerling et al, 2018). Malik et al. (2016) provided information on the
recurrence rate (age-standardized recurrence risk of 1.15%; n=65,148) of patients who were
operated on in the Shouldice repair at the Shouldice hospital. But in terms of SSI, SSO and
postoperative outcome in general no current information from our Shouldice hospital has been
revealed within the last two decades (Malik et al, 2016).
In order to further optimize, evaluate, and increase knowledge of the Shouldice repair
systematic follow-up of patients who were operated on at the Shouldice Hospital should be
updated. The current project aims to perform a systematic follow-up of patients for the
purpose of supporting the ongoing improvement of patient care and knowledge. This study will
act as a pilot for refining our long term follow up, focused on patient and surgical
outcomes.
Study Objectives:
1. Establish a patient reported outcome measure follow up program at Shouldice Hospital
2. Evaluate the postoperative complication rate (pain, infection, recurrence, and other
complications)
3. Determine the reasoning and important outcomes to patients who undergo hernia repair at
Shouldice Hospital.
4. Establish and monitor patient satisfaction with decision making and hernia repair.
Hypothesis/Research Questions:
1. What were the most common reasons for patients to undergo hernia repair?
2. What was the most reported important outcome to patients after hernia surgery?
3. Did patients feel they had adequate knowledge and feel a part of the decision-making
process?
4. How satisfied and confident were patients with their Shouldice hernia repair at 1-year
after surgery?
5. Was there any improvement in quality of life due to hernia repair noted at 1-year after
surgery?
6. What is the infection rate, pain incidence, and hernia recurrence rate at 30-days after
hernia repair at Shouldice Hospital?
7. What is the pain incidence and hernia recurrence rate at 1-, 3-, and 5-years after
hernia repair at Shouldice Hospital?
8. Is there a difference in pain experienced after surgery by patients based off the hernia
they had repaired?
9. Does infection rate differ depending on hernia and/or hernia repair?
10. Does infection rate differ for those given or not given antibiotics prior to or during
surgery?
Potential Risks and Benefits:
There are no known or anticipated risks to participants as individuals or as part of an
identifiable group. This includes no physical, psychological, or emotional, social, and/or
data security breach risks. The use of information will remove any personal identifiers
before data analysis. There are no direct benefits to the participants from their involvement
in the project and these include no education about research methods or useful knowledge
about self.
Study Design:
The current study is a prospective follow up of patients who had an operation for a hernia at
the Shouldice Hospital. The study design includes using an automated report generated for
follow up which will allow for participant identification and provide necessary information
to send the consent forms and follow up to patients, as well as responses from follow up
surveys by email, and manual review of charts and operative notes. All patients that had
surgery at Shouldice Hospital are included unless they did not have an email address. The
reason for this exclusion is due to the electronic and internet-based nature of the project.
Patients will be emailed 30-40 days after surgery, as well as 1-year, 3-years, and 5-years
after surgery using the Hospital's current survey site: Simple Survey. Each email will have a
link to a consent form, which will provide potential participants with the choice to be taken
directly to the survey if they have consented, decline to participate, or be provided with
information to contact a research team member. Patients that do not respond after the
30-40-day postoperative survey will be contacted by phone; this is to ensure comprehensive
data collection regarding infection at 30-40 days after surgery. Patients that respond yes to
infection questions at the 30-40-day postoperative survey will additionally be asked if we
can contact them via telephone to follow up on their potential infection.
The survey is designed to capture the results of important questions and aims about this
study. The 30-40 day and 1-year postoperative survey includes a postoperative recovery,
preoperative decisions and hernia repair, and final questions and comments section. The 3-
and 5-year postoperative surveys have the postoperative recovery and final questions and
comments sections. The postoperative recovery portion includes questions regarding pain and
swelling (30-40 day/1-year/3-year/5-year survey) from HerniaMed (Stechemesser et al, 2012),
questions regarding infection, fluid formation, and hematoma pertaining to grade of surgical
site infection and surgical site occurrence (30-40 day survey), and additional questions
regarding hernia relapse (30-40 day/1-year/3-year/5-year survey) and wound complication
(30-40 day survey). Another part of the survey pertains to preoperative decisions and hernia
repair. The 30-40-day postoperative survey enquires about the reasons for surgery, which was
used for our purposes of analyzing the reason for having surgery but tailored from Smith et
al (2022). This paper by Smith et al (2022) found five superordinate themes when studying
what matters to abdominal wall hernia patients, which included body image, mental health,
symptoms, interpersonal relationships, and employment. After these questions, patients are
asked what the most important outcome was to them after surgery. This question is asked on
the 30-40-day postoperative survey and may hold some hindsight bias, but we felt it was
important that our ongoing research include these types of questions as patient's responses
may differ from the current documented reasons for surgery and important outcomes. Additional
questions on the 30-40-day postoperative survey was asked on the knowledge patients had
regarding hernia surgery and recovery and how patients felt about being a part of the
decision-making process. After reading Rossello Jimenez et al (2022) paper, which was done to
understand patient knowledge of hernia surgery (self-reported), we decided that the other
variables, when trying to understand important patient perspectives for patient reported
outcomes, included if patients had adequate knowledge regarding surgery and recovery as well
as if they felt a part of the decision-making team. The preoperative decisions and hernia
repair section differs on the 1-year postoperative survey. At the 1-year postoperative time
the survey asks patients questions about satisfaction with hernia repair, outcome of hernia
repair, and improvement of quality of life with hernia repair. These questions were adapted
from the hernia quality of life assessment instrument (HERQL) (Huang et al, 2017). The final
part of the surveys allow for further context to patients attitudes towards the Hospital, any
major life events that may affect recovery, and additional space for comments.
Study Population:
The population will focus on all patients aged 16-90 years of age, standard age of patients
accepted for surgery at Shouldice Hospital, who had a hernia operation at Shouldice Hospital.
The only exclusion criteria are those without an email address. The reason for this exclusion
is due to the electronic and internet-based nature of the project. As this is the first study
of its kind at Shouldice Hospital the required sample size is unknown, and this study will
act as an initial pilot for systematic follow up focused on patient and surgical outcomes.
However, for the infection rate analysis we know that to compare to the publications on
Shouldice Repair in Europe that were written within the last two decades, which had 3,888
individuals combined (Bittner et al. 2005, n=1773; Köckerling et al. 2018, n=2115), we will
aim to analyze information from 2,000 patients to allow for a meaningful scientific
comparison with current knowledge. Therefore, we aim to contact 4,500 patients in order to
analyze a total of 2,000 patients. This is based off information gathered by this institution
from previously done prospective projects. When initial research contact was emailed, there
was a response rate of 45%. No dropout rate has been measured as we will gather data for this
study to go on with a sample size calculation in the future.
Data Collection:
This study will use recorded sources (responses to surveys, patient charts, and operative
notes) to collect information. This will include a research team member manually checking
patient charts and operative notes as well as downloading and inputting survey responses.
Surveys are sent at 30-40 days, 1-year, 3-year, and 5-year postoperative time. Provided in
supplemental material is a list of the data we will be collecting to use in data analysis and
during the explanations of results.
A study personnel will identify potential study participants through a report that is
generated daily, using the hospital database, which is sent and stored as an excel file on
the hospitals secure network (EDrive). Only research team personnel will have access to these
excel files. The report shows patient Hospital account number, patient first and last name,
discharge date, length of hospital stay, patient email address, as well as patient
information (sex, smoker, height, and weight). The automated report will be used by a study
personnel to upload and send surveys, utilizing SimpleSurvey, at the postoperative times. The
contacting person will not be already known to potential participants when making initial
contact, however, the potential participants will be known to Shouldice Hospital as they will
have had an operation here.
For the purposes of this research project, composed of simple review of charts and operative
notes as well as follow up for patient reported outcomes, a consent alteration is requested
(deferred consent). As the request for altered consent pertains to TCPS2 3.7A this research
project presents as no more than minimal risk to the participants, an alteration to the
consent requirement is unlikely to adversely affect the welfare of participants, and it may
be impractical (Government of Canada, 2018) to carry out a large scale follow up initiative
without an altered consent process. The altered consent process would compromise of deferred
consent so that initial contact to send consent forms can be achieved. In person consenting
would be impractical as the current hospital procedures for patient intake and during
hospital stay would be onerous to other departments as well as a burden to the small number
of research department staff. In regard to TCPS2 3.7B each postoperative contact email will
immediately notify potential participants of the research project and will have a link to the
consent form to ensure consent is obtained and ongoing. On each of the consent forms
potential participants will have the choice to be taken directly to the survey if they have
consented, decline to take part, or be provided with information to contact a research team
member. Potential participants can take as long as they want to decide about participation,
but the nature of the study focuses on data collection at specific postoperative intervals.
This research is not being done under medical emergencies or involving those with diminished
decision-making capacity (TCPS2 3.8-3.11). In regard to PHIPA, this research project will be
submitted to an ethics board and researchers will comply with the outlined compliance in
section 44. In order to ensure potential participants meet the criteria for follow up (have
an email address) and to send a consent form, we require personal information without direct
consent, but will obtain consent prior to the collection of all additional information which
was not provided in the automated report. Potential participants will be informed about the
opportunity to withdraw at any time. By doing so potential participants can refuse to
participate or request additional contact/information by research personnel. Steps are taken
to safeguard personal health information by password protection and safe storage.
Overlap with other projects is a concern as we aim to have multiple studies running. However,
there will be additional populations under review in this project (all hernia types and
recurrences) and this project is specifically aimed to pilot a systemic follow up program.
Standard follow up procedures and concurrent research participation can be routine practices.
Participants will be able to withdraw from participation at any time as well as decline to
participate.
Duration of Study:
The study is estimated to take 5-6 years from the beginning of data collection until
finishing the write up of results. Recruitment/enrollment will take 6-12 months, follow up
will take 5 years from last enrolled participant, and data analysis and study write up will
take 5 months. The time it takes for publication is not taken into consideration. Duration of
participant participation is dependent on which and how many follow up surveys are completed.
It is estimated to take 5 minutes for consent form review (multiplied by 4 consent forms),
3-5 minutes for the 30-40 day postoperative survey, 3 minutes for the 1-year postoperative
survey, and 4 minutes for 3- and 5-year postoperative surveys (2 minutes each). The surveys
are sent to patients 30-40 days, 1-year, 3-years, and 5-years after surgery. There will only
be a follow up phone call reminder for those who don't complete and respond yes to being
contacted in regard to the infection questions at the 30-40 day postoperative survey.
