The CIPHER Study (Phase B)

Funder: NIHR/HTA

Status: In Follow Up

During abdominal surgery it is sometimes necessary to create a stoma to divert faeces or urine from the intestinal or urinary tract 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 a hernia immediately adjacent and related to the stoma that occurs when the muscle in the body wall splits; contents of the abdomen, e.g. fatty tissue or intestine, can be forced through the split in the muscle causing a bulging of 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 patient 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 itself a risk factor for recurrence of a hernia. Stopping a PSH forming in the first place is therefore very important.

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 mesh 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.

The CIPHER study aims: (a) to establish the incidence of symptomatic and radiologically confirmed PSH during a minimum of 2 years follow up; and (b) to evaluate the effects of key technical surgical steps when a stoma created on the risk of developing a PSH. To achieve these aims, some preliminary research (Phase A) needs to be carried out to enable the main study (Phase B) to be designed optimally.

Objectives of Phase A are:

A1   To define key technical surgical steps when a surgeon creates a stoma and how these steps vary between surgeons.

A2   To develop a questionnaire for patients to report symptoms of PSH.

Objectives of Phase B are:

  1. To describe the incidence of PSH formation within 2 years of creation of a stoma and how the risk of PSH varies for different types of stoma.
  2. To describe the risk of PSH according to the way the surgeon creates an opening in the abdominal wall.
  3. To describe the risk of PSH according to whether a mesh is used and, if yes, the type of mesh and how it is used.
  4. If a mesh used, to describe the risk of PSH according to how it is used.

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Chief Investigator: Professor Neil Smart, Consultant Colorectal Surgeon, Royal Devon University Healthcare NHS Foundation Trust

Study Manager: Lucy Ellis