CIPHER Phase A: Understanding surgical practice and developing a PROM
UK Cohort study to Investigate the prevention of Parastomal HERnia (CIPHER) Phase A Protocol: Understanding surgery and current practice in stoma formation and developing Patient Reported Outcome Measures for Parastomal Hernia to inform Phase B of CIPHER
University of Bristol
Duration of Study in the UK
2 years, 0 months, 0 days
During abdominal surgery it is sometimes necessary to form a stoma (ileostomy, colostomy), with 20,000 created annually in the UK. Having a stoma means that a section of bowel is passed through the abdominal wall. The bowel can then empty its contents (stool and faeces) into a bag worn externally. A complication of stoma formation is the development of a Parastomal Hernia (PSH), which we think occurs in up to 40% of patients. A PSH is a swelling next to the stoma whereby abdominal contents protrude underneath the skin. It may cause pain and/or difficulties with stoma bag fixation. Anxiety and embarrassment associated with PSH can influence sexual function, social interaction and work. Hospital admission may be required if a section of bowel is caught in the PSH, causing serious complications. Prevention of PSH is therefore a priority.
The National Institute for Health Research (NIHR) has funded this study to investigate the prevention of PSH (The CIPHER Study). Phase A of the CIPHER study will firstly involve interview and observation work to understand the key components of how stomas are formed in the operating theatre. Researchers will observe how stomas are created by a variety of surgeons in theatre, followed by interviews with the operating surgeon (Part 1 of Phase A). This will enable a detailed understanding of stoma formation in order to identify which surgical steps might be important in preventing PSH. Secondly, work in Phase A will develop and modify questionnaires that patients will complete in order to elicit symptoms associated with PSH (Part 2 of Phase A), so that these can be accurately detected in Phase B, the main cohort study. Researchers will interview patients to ask for their views on problems of living with a PSH. Both outputs will be tested and used in Phase B.
East Midlands - Nottingham 1 Research Ethics Committee
Date of REC Opinion
4 May 2016
Further Information Favourable Opinion