UK cohort study to investigate the prevention of parastomal hernia
| ISRCTN | ISRCTN17573805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17573805 |
| Secondary identifying numbers | CPMS 35821 |
- Submission date
- 27/11/2017
- Registration date
- 01/02/2018
- Last edited
- 27/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
During abdominal surgery, it is sometimes necessary to create a stoma (an opening) to divert faeces from the bowel into an external pouch or bag. Unfortunately, the formation of the stoma can be associated with future complications, including the risk of developing a parastomal hernia (PSH). A PSH is an incisional hernia, immediately adjacent and related to the stoma that occurs when the fascia (a band of connective tissue) in the abdominal wall splits. Contents of the abdomen, e.g. fatty tissue or intestine, can be forced through the split in the fascia causing a bulge in the skin. PSH are relatively common and affect approximately 40% of patients within 2 years of their bowel surgery. Complications of PSH can be severe and are known to negatively influence patients’ quality of life. Specifically, PSH can make it difficult to attach stoma bags which can cause the bag contents to leak and smell, irritate the surrounding skin and make patients anxious and avoid social situations. PSH can also cause pain and serious problems, e.g. bowel obstruction, which need emergency treatment in hospital. PSH are difficult to manage and in most cases treatment involves specialist stoma care with expensive appliances. In some cases, a surgeon may reoperate to repair the hernia but additional surgery is risky and recurrence of a hernia is not uncommon. Therefore, it is very important to prevent a PSH forming in the first place. Both patient and surgical factors are believed to influence the development of PSH. Of the surgical factors, the size and shape of the incision in the body wall, the use of mesh when the stoma is formed and, if mesh is used, exactly how it is used, have all been described as potentially important considerations. However, the way in which surgeons create stomata is very varied and research is needed to investigate whether these factors influence the risk of developing a PSH. The aim of this study is to establish the incidence of PSH over a period of two years and to evaluate the effects of key technical surgical steps that influence the risks of PSH formation.
Who can participate?
Adults aged 18 and older who are undergoing a surgery to create a stoma.
What does the study involve?
Participants are approached about the study before their surgery by a stoma care nurse or other appropriately trained and qualified member of the direct care team and given a patient information leaflet. Once the participant has consented, baseline details will be collected prior to their surgery and the participant is asked to complete a baseline questionnaire. Details about their surgery are collected by the surgical team in theatre. Post-operative data is collected by the stoma care nurses or research nurses at discharge. Participants are asked to complete questionnaires at set intervals (about 6 weeks after surgery and then at 6, 12, 18 and 24 months after surgery). Participants are given the option to complete the questionnaires by post or online. If the participant agrees, they may continue to complete the 6 monthly questionnaires up to the end of the whole study period (at 30, 36, 42 and 48 months after surgery). The questionnaires include quality of life questionnaires and questionnaires about symptoms relating to their stoma. Participants are also asked if they have been admitted to hospital or had a CT scan since their last questionnaire. Any CT scans the participant has had are requested from the hospital and reviewed by surgical trainees. Participants also consent for details to be collected from NHS Digital and databases containing records of contacts with stoma care nurses and stoma products prescribed periodically throughout the study.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating. This is because nothing about their operation or aftercare will change. We simply wish to collect details about their surgery and recovery to better understand why some patients develop parastomal hernias and others do not. This information will be very useful to the NHS and future patients.
Where is the study run from?
This study is being run by University of Bristol (UK) and takes place in hospitals in the UK.
When is the study starting and how long is it expected to run for?
October 2016 to January 2024
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Miss Lucy Ellis (Scientific)
cipher-study@bristol.ac.uk
Contact information
Scientific
CIPHER Study Coordination Team
University of Bristol
Bristol Trials Centre
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
 ORCID ID |
0000-0001-8179-5172 |
|---|---|
| Phone | +44 (0)117 455 9216 |
| Cipher-study@bristol.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The CIPHER study: UK Cohort study to Investigate the prevention of Parastomal HERnia |
| Study acronym | The CIPHER study |
| Study hypothesis | Current study hypothesis as of 30/04/2024: The CIPHER study aims to establish the incidence of symptomatic and clinically confirmed PSH during a minimum of 2 years follow up. Additionally, CIPHER aims to evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent PSH formation. _____ Previous study hypothesis: The CIPHER study aims to establish the incidence of symptomatic and radiologically confirmed PSH during a minimum of 2 years follow up. Additionally, CIPHER aims to evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent PSH formation. |
| Ethics approval(s) | West Midlands - Black Country Research Ethics Committee, 08/11/2017, ref: 17/WM/0401 |
| Condition | Colorectal surgery for hernia |
| Intervention | Once a participant has consented, baseline details are collected prior to their index surgery and the participants are asked to complete a baseline questionnaire. Intra-operative details are collected by the surgical team. Post-operative data is collected at discharge. Participants are followed up for a minimum of 2 years post index surgery and are asked to complete questionnaires at set intervals (about 6 weeks after surgery and then 6, 12, 18 and 24 months after surgery). Participants have the option to complete the questionnaire by post or online. If the participant agrees, they may continue to complete the 6 monthly questionnaires up to the end of the whole study period (maximum 4 years). The questionnaires include quality of life questionnaires (EQ-5D-5L & SF-12) and questionnaires to ascertain symptoms of PSH. Participants are also asked if they have been admitted to hospital or had a CT scan since their last questionnaire. Any CT scans are requested from the hospital and reviewed by surgical trainees to ascertain whether PSH is radiologically evident. Participants consent for details to be collected from NHS Digital and databases containing records of contacts with stoma care nurses and stoma products prescribed periodically throughout the study. Patient involvement in the study finishes once all questionnaires have been submitted. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 30/04/2024: PSH incidence during follow-up after index surgery to form a stoma (an incident PSH is defined as symptoms of PSH and clinical PSH) are assessed using a custom-designed questionnaire and participants’ reports of having “been told by a nurse or doctor that you have a parastomal hernia” at 6, 12, 18 and 24 months after surgery. _____ Previous primary outcome measure: PSH incidence during follow-up after index surgery to form a stoma (an incident PSH is defined as symptoms of PSH and anatomical PSH) are assessed using a custom-designed questionnaire and CT scans at 6 weeks and 6, 12, 18 and 24 months after surgery. |
| Secondary outcome measures | Current secondary outcome measures as of 08/09/2021: 1. Intensive care unit (ICU) stay (days) are recorded during admission for index surgery 2. Hospital stay (days) are recorded during admission for index surgery 3. Surgical site infection is measured using a questionnaire during admission for index surgery and 30 days afterward 4. Other complications are documented using the Clavien Dindo classification and the Comprehensive Complication Index at discharge 5. Symptoms of PSH are measured using a questionnaire at 12 months after index surgery 6. Generic health status is assessed using the EQ-5D-5L, SF12 scales at baseline and follow up time points: 6 weeks, 6, 12, 18, and 24 months after index surgery 7. Appointments with SCNs and advice about stoma care products 8. PSH repair is assessed using procedure codes for stoma formation in HES, information from SCNs 9. Health and social care resource use is measured using HES data at the end of the study 10. PSH identified from CT scan assessment by surgical trainees if CT scan is reported by participants in questionnaires at 6 weeks, 6, 12, 18, and 24 months after index surgery _____ Previous secondary outcome measures: 1. Intensive care unit (ICU) stay (days) are recorded during admission for index surgery 2. Hospital stay (days) are recorded during admission for index surgery 3. Surgical site infection is measured using a questionnaire during admission for index surgery and 30 days afterwards 4. Other complications are documented using the Clavien Dindo classification and the Comprehensive Complication Index at discharge 5. Symptoms of PSH are measured using a questionnaire at 12 months after index surgery 6. Generic health status is assessed using the EQ-5D-5L, SF12 scales at baseline and follow up time points: 6 weeks, 6, 12, 18 and 24 months after index surgery 7. Appointments with SCNs and advice about stoma care products 8. PSH repair is assessed using procedure codes for stoma formation in HES, information from SCNs 9. Health and social care resource use is measured using HES data at the end of the study |
| Overall study start date | 01/10/2016 |
| Overall study end date | 29/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 4000; UK Sample Size: 4000 |
| Total final enrolment | 2500 |
| Participant inclusion criteria | 1. Aged 18 years or over 2. Able to give written informed consent 3. Undergoing elective or expedited surgery to create a stoma; either an ileostomy or colostomy |
| Participant exclusion criteria | Current exclusion criteria as of 19/12/2018: 1. Lacking the capacity to consent 2. Having emergency surgery 3. Previous abdominal wall stoma 4. Life expectancy <12 months from the index procedure 5. Having surgery with intention of forming a double-barrelled stoma 6. Having surgery with intention of forming a urostomy Previous exclusion criteria: 1. Lacking the capacity to consent 2. Having emergency surgery 3. Previous abdominal wall stoma 4. Life expectancy <12 months from the index procedure 5. Having surgery with the intention of forming a loop ileostomy 6. Having surgery with intention of forming a double-barrelled stoma 7. Having surgery with intention of forming a urostomy |
| Recruitment start date | 11/12/2017 |
| Recruitment end date | 30/06/2021 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Barrack Road
Exeter
EX2 5DW
United Kingdom
Bristol
BS2 8HW
United Kingdom
Bristol
BS10 5NB
United Kingdom
Truro
TR1 3LQ
United Kingdom
Higher Kingston
Yeovil
Somerset
BA21 4AT
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Salisbury
Wiltshire
SP2 8BJ
United Kingdom
Burton Road
Kendal
LA9 7RG
United Kingdom
Armthorpe Road
Doncaster
South Yorkshire
DN2 5LT
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Basildon
SS16 5NL
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
King's Lynn
PE30 4ET
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
King's Mill Hospital
Mansfield Road
Sutton in Ashfield
NG17 4JL
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Egerton Road
Guildford
GU2 7XX
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Oxford Rd
Manchester
M13 9WL
United Kingdom
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Ashton-under-Lyne
OL6 9RW
United Kingdom
Norwich
NR4 7UY
United Kingdom
Chester
CH2 1UL
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Arrowe Park Rd
Birkenhead
Wirral
CH49 5PE
United Kingdom
Turner Road
Colchester
CO4 5JL
United Kingdom
Victoria Rd
Macclesfield
SK10 3BL
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Crewe
Cheshire
CW1 4QJ
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Stockton on Tees
Cleveland
TS19 8PE
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Sibsey Road
Boston
PE21 9QS
United Kingdom
Chesterfield
S44 5BL
United Kingdom
Thornton Heath
Croydon
CR7 7YE
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
South Wharf Road
St Mary's Hospital
London
W2 1NY
United Kingdom
Salford
M6 8HD
United Kingdom
Poole
BH15 2JB
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Guildford Road
Chertsey
KT16 0PZ
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Derby
DE22 3NE
United Kingdom
Kayll Rd
Sunderland
SR4 7TP
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Paisley
PA2 9PJ
United Kingdom
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom
Gateshead
NE8 4YL
United Kingdom
Swindon
SN3 6BB
United Kingdom
Birmingham
B9 5SS
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Belvedere Rd
Burton-on-Trent
DE13 0RB
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Fazakerley
Liverpool
L9 7AL
United Kingdom
Glasgow
G4 0SF
United Kingdom
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Worcester
WR5 1DD
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Manchester
M20 4BX
United Kingdom
Lakin Road
Warwick
CV34 5BW
United Kingdom
Warrington Rd
Rainhill
Prescot
L35 5DR
United Kingdom
Great Western Road
Gloucester
GL1 3NN
United Kingdom
College Street
Nuneaton
CV10 7DJ
United Kingdom
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
England
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings will be presented at national/international conferences, published in peer-reviewed academic journals, professional media (e.g. to SCNs) and accessible formats in newsletters to patients, in accordance with advice from the PPI group about how best to do this effectively. The findings will also be reported as a briefing paper to commissioners (e.g. commissioning groups, NICE) and to other health care stakeholders with an interest in the research. |
| IPD sharing plan | The study data may be shared for other research (by researchers in NHS or academic institutions) relating to patients who have stomas at any time, providing the data are used for objectives that do not overlap with the CIPHER study objectives. Data relating to CIPHER study objectives may be shared for secondary research after the publication of the main results. NHS digital data (HES data) will not be shared. Data will only be shared where participants have agreed for it to be used in future ethically approved research. In all instances, sharing of anonymised individual patient data should be conditional on assurance from the researcher that the proposed use of the data is compliant with the MRC Policy on Data Preservation and Sharing regarding scientific quality, ethical requirements and value for money. A minimum requirement with respect to scientific quality will be a publicly available pre-specified protocol describing the purpose, methods and analysis of the research, e.g. a study protocol or a protocol for a Cochrane systematic review. The second file containing patient identifiers would be made available for record linkage or a similar purpose, subject to confirmation that the secondary research protocol has been approved by a UK REC or other similar, approved ethics review body. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/07/2021 | 09/06/2021 | Yes | No | |
| Other publications | What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention | 05/10/2022 | 06/10/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 5.0 | 05/01/2024 | 30/04/2024 | No | No |
Additional files
Editorial Notes
27/09/2024: The intention to publish date has been changed from 01/04/2025 to 01/04/2026.
30/04/2024: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The study hypothesis was changed.
3. The overall end date was changed from 01/12/2022 to 29/01/2024.
4. Uploaded protocol (not peer-reviewed) as an additional file.
06/10/2022: Publication reference added.
21/09/2022: The intention to publish date was changed from 31/07/2023 to 01/04/2025. IPD sharing statement added.
14/09/2022: Total final enrolment added. The overall trial end date was changed from 01/09/2022 to 01/12/2022.
13/06/2022: The scientific contact's details have been changed.
10/06/2022: The sponsor name has been changed from Royal Devon and Exeter NHS Foundation Trust to Royal Devon University Healthcare NHS Foundation Trust following a merger. The trial participating centre has been updated accordingly.
08/09/2021: The secondary outcome measures have been updated.
09/06/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 30/06/2021.
2. The overall trial end date has been changed from 30/04/2022 to 01/09/2022.
3. The intention to publish date has been changed from 01/12/2022 to 31/07/2023.
4. The scientific contact has been updated.
5. Publication reference added.
6. 77 Trial participating centres have been added.
8. The plain English summary has been updated to reflect the changes above.
13/07/2020: The trial contact details have been made publicly visible.
10/01/2020: The recruitment end date has been changed from 10/12/2019 to 30/06/2021.
27/03/2019: The condition has been changed from "Specialty: Surgery, Primary sub-specialty: Colorectal Surgery; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system" to "Colorectal Surgery for hernia" following a request from the NIHR.
19/12/2018: The participant exclusion criteria have been changed.
