The CIPHER study
Research type
Research Study
Full title
UK Cohort study to Investigate the prevention of Parastomal Hernia
IRAS ID
210716
Contact name
Neil Smart
Contact email
Sponsor organisation
Royal Devon & Exeter NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
During abdominal surgery, it is sometimes necessary to create a stoma 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 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. This is the aim of the CIPHER study.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
17/WM/0401
Date of REC Opinion
8 Nov 2017
REC opinion
Further Information Favourable Opinion