The CIPHER study: UK Cohort study to Investigate the prevention of Parastomal HERnia
Colorectal surgery for hernia
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.
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
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