UK cohort study to investigate the prevention of parastomal hernia

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17573805

Enrollment

4000

Registered

2018-02-01

Start date

2017-12-11

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal surgery for hernia Surgery Colorectal surgery

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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, informatio	—

Measure

Time frame

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, informatio

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Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026