PROPHER: Quality-of-life feedback using patient-reported outcomes after treatment of parastomal hernia
| ISRCTN | ISRCTN32116071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32116071 |
| IRAS number | 298207 |
| Secondary identifying numbers | CPMS 52007, BRUK334, IRAS 298207 |
- Submission date
- 17/07/2023
- Registration date
- 17/08/2023
- Last edited
- 21/08/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
PROPHER stands for Patient Reported Outcomes after Parastomal Hernia Treatment. The overall aim of the PROPHER study is to see what the impact on the patient’s quality of life is from having treatment for a parastomal hernia. The study will also look at how parastomal hernias are treated, for example having an operation and any complications that happen in the first 30 days, or deciding to “watch and wait”. It will also look at whether there are any links between the way that a surgeon repairs a parastomal hernia and the outcomes.
What is a parastomal hernia? Stoma formation is often necessary after bowel surgery. A common complication of a stoma is a parastomal hernia (PSH) - caused by a weakness in the abdominal muscle which results in a local bulge next to or behind the stoma. A PSH can cause skin irritation, problems with getting a stoma bag to stick, as well as pain and other more serious complications such as bowel obstruction. These issues often have a negative impact on a patient’s quality of life.
What are patient-reported outcomes? Patient-reported outcome measures (PROMs) are questionnaires that measure the patient’s view of their own health. Questionnaires are completed before and after treatment so that healthcare professionals and researchers can see how the treatment has impacted the patient.
Who can participate?
Patients aged 18 years or above with a symptomatic parastomal hernia. This includes those referred to a colorectal surgeon for consideration of surgical treatment or seen by a clinical nurse specialist. Patients undergoing surgical treatment or conservative/watchful waiting are eligible for entry.
What does the study involve?
Participants will be asked to complete questionnaires about their parastomal hernia as well as information about how they feel at various stages throughout their treatment. These details will be collected at the start (baseline), at 3 months, 6 months and at 12 months. The hospital team will also record some additional information about the participant's medical history, and if patients have an operation as part of their treatment, they will record details about the surgery.
What are the possible benefits and risks of participating?
We do not expect any risk to study participants. Joining the study will not have any impact on patient care as participants will be receiving the same treatment they would if they do not join the study. Participants might find messages reminding them to complete the questionnaires a minor inconvenience given that the study follow-up period continues up to 12 months after joining the study.
There will not be any direct personal benefit to joining the study. However, the data collected from the study will translate into direct benefits for patients in the future. It is possible that a patient participating in PROPHER will not achieve successful PSH treatment during the lifetime of the study, or they will develop a new or recurrent PSH in the future. As such an individual may also be able to personally benefit from their involvement in the study.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
March 2021 to August 2028
Who is funding the study?
Bowel Research UK and the European Society of Coloproctology (ESCP)
Who is the main contact?
Rita Perry, r.perry.1@bham.ac.uk
Contact information
Scientific
Birmingham Centre for Observational and Prospective Studies
Public Health Building
University of Birmingham
Birmingham
B29 2TT
United Kingdom
 ORCID ID |
0000-0001-5284-8634 |
|---|---|
| Phone | +44 (0)121 414 9106 |
| r.perry.1@bham.ac.uk |
Principal Investigator
Birmingham Clinical Trials Unit
Public Health Building
University of Birmingham
Birmingham
B29 2TT
United Kingdom
| ORCID ID |
0000-0001-7320-6673 |
|---|---|
| Phone | +44 (0)121 414 9012 |
| thomas.pinkney@uhb.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Internet/virtual, Medical and other records |
| Study type | Quality of life |
| Participant information sheet | 43966_PIS_v5.0_21Jun2023.pdf |
| Scientific title | Patient Reported Outcomes after parastomal hernia treatment - a prospective international cohort study |
| Study acronym | PROPHER |
| Study objectives | A prospective international cohort study of parastomal hernia (PSH) treatment, including both operative and non-operative interventions. A global network of clinicians and specialist nurses will collate detailed information on individual interventions used and short-term outcomes, then patients will provide their own medium and longer-term outcomes data including whether their treatment was successful, via a secure online/mobile phone-based system. The study will provide a wealth of contemporaneous information which will improve our ability to counsel patients and facilitate improved selection of appropriate and personalised interventions for those with a PSH. |
| Ethics approval(s) |
Approved 04/04/2022, South Central - Hampshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8064; hampshireb.rec@hra.nhs.uk), ref: 22/SC/0060 |
| Health condition(s) or problem(s) studied | Parastomal hernia (PSH) treatment |
| Intervention | PROPHER is an international multi-centre prospective cohort study. A global network of clinicians and specialist nurses will enrol adults over the age of 18 years with a symptomatic parastomal hernia (PSH) for which treatment or intervention is being sought. the study is observational only - no intervention will be decided by the study protocol and is instead as per treating clinician's decision. Patients undergoing both operative and non-operative interventions will be included, and identical outcome measures obtained for both populations. These outcome measures of treatment success will be almost exclusively patient-reported up to one year after study and include quality of life, stoma-specific symptom scores and additional treatments including hospital admission. In addition, a modified MYMOP (Measure Yourself Medical Outcomes Profile) will be obtained at study entry and this entirely personalised outcome measure assessed individually at study exit (12 months). A decisional regret analysis will also be obtained at study exit. Patients undergoing surgical intervention during the study period will have additional detailed information recorded about the operative techniques employed so we can assess any impacts, beneficial or otherwise, on patient-reported outcomes. If a patient in the conservative management arm undergoes surgical repair of their parastomal hernia during the 12-month follow-up period, they will automatically cross over into the surgical group. |
| Intervention type | Other |
| Primary outcome measure | This study will collect a range of clinical and patient-reported outcome measures. There is no explicit primary outcome measure. Patient-reported outcomes: 1. Health-related quality of life reported by the participant using the SF-12 score at baseline and 3, 6 and 12 months post-enrolment 2. Stoma impact reported by the participant using the Stoma Impact Score at baseline and 3, 6 and 12 months post-enrolment 3. Impact of the key symptom or issue the patient is hoping will be improved by their PSH treatment assessed using the modified Measure Yourself Medical Outcomes Profile (MYMOP) at baseline and 12 months post-enrolment 4. Decisional regret assessed using the Decision Regret Scale at 12 months post-enrolment Clinician-reported outcomes based on routinely collected data held in patient notes transcribed into electronic case report forms (eCRFs): 1. Patient demographics – including BMI, smoking status and comorbidities assessed using the online case report form (CRF) for the study at baseline 2. PSH details - including index operation, PSH characteristics and symptoms, previous treatments for this PSH - assessed using the online CRF at baseline 3. In those undergoing surgical repair: 3.1. Operation details – including technique employed, type and location of mesh placement (if appropriate) assessed using the online CRF at time of surgery 3.2. Short-term post-operation details assessed using the online CRF up to 30 days post-surgery, including: 3.2.1. Postoperative complications assessed using the Clavien-Dindo Scale 3.2.2. Postoperative complications assessed using the comprehensive complication index (CCI) 3.2.3. Length of stay 3.2.4. Unplanned re-operation 4. In those undergoing non-operative management: 4.1. Details of conservative treatment instigated, including support wear, physiotherapy, other advice given assessed using the online CRF at baseline |
| Secondary outcome measures | There are no additional outcome measures |
| Overall study start date | 01/03/2021 |
| Completion date | 15/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1500; UK Sample Size: 500 |
| Key inclusion criteria | 1. Adult, aged 18 years and above. 2. A stoma formed from any part of the bowel – whole small bowel and colon, and of any format – including loop, end, double barreled, Abcarian, other 3. All treatments for PSH, including conservative (non-operative) treatment and surgical intervention. All types of surgical approach are included. 4. Elective presentations to outpatient services, including surgical, colorectal, stoma care team are included. Patients presenting primarily as an emergency with a symptomatic PSH requiring urgent intervention are also eligible for inclusion, providing informed consent can be obtained. |
| Key exclusion criteria | 1. Patients with an isolated urostomy 2. Life expectancy less than 12 months 3. Proposed treatment plan for dealing with PSH involves restoration of gut continuity meaning that patient will have no stoma after treatment. 4. Anyone who does not have an email address or does not have access to the internet or a smart device |
| Date of first enrolment | 21/08/2023 |
| Date of final enrolment | 09/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Edgbaston
Birmingham
B15 2WB
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Leicester
LE1 5WW
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Ashton Road
Lancaster
LA1 4RP
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Chertsey
KT16 0PZ
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
York
YO31 8HE
United Kingdom
Bedford
MK42 9DJ
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
Walsgrave
Coventry
CV2 2DX
United Kingdom
Warwick
CV34 5BW
United Kingdom
Truro
TR1 3LJ
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Dudley
DY1 2HQ
United Kingdom
Sponsor information
Hospital/treatment centre
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bowel Research United Kingdom, BRUK
- Location
- United Kingdom
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- The European Society of COLOPROCTOLOGY, European Society of Coloprotology, ESCP
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 15/08/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal around one year after the study end date. We will also publicise the results on the study’s website: www.escp.eu.com/research/cohort-studies/2019-patient-reported-outcomes-after-parastomal-hernia-treatment. No individual patients will be identifiable in any publications. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 5.0 | 21/06/2023 | 03/08/2023 | No | Yes |
Additional files
Editorial Notes
21/08/2023: The recruitment start date has been changed from 17/08/2023 to 21/08/2023.
18/08/2023: Internal review.
17/07/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
