Condition category
Surgery
Date applied
27/11/2017
Date assigned
01/02/2018
Last edited
01/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 April 2022

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Hana Tabusa (Scientific)
cipher-study@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Hana Tabusa

ORCID ID

http://orcid.org/0000-0002-2052-8844

Contact details

Clinical Trials Evaluation Unit (CTEU)
School of Clinical Sciences
University of Bristol
Level 7
Queens Building
Bristol Royal Infirmary
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35821

Study information

Scientific title

The CIPHER study: UK Cohort study to Investigate the prevention of Parastomal Hernia

Acronym

The CIPHER study

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

West Midlands - Black Country Research Ethics Committee, 08/11/2017, ref: 17/WM/0401

Study design

; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Surgery, Primary sub-specialty: Colorectal Surgery; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system

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

Phase

Drug names

Primary outcome measures

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

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 trial start date

01/10/2016

Overall trial end date

30/04/2022

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 4000; UK Sample Size: 4000

Participant 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

10/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

University Hospital Bristol NHS Foundation Trust
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Road
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LQ
United Kingdom

Sponsor information

Organisation

Royal Devon and Exeter NHS Foundation Trust

Sponsor details

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes