The PROPHER study: patient-reported outcomes after parastomal hernia treatment-a prospective international cohort study

Aim: A significant proportion of stoma patients develop a parastomal hernia (PSH), with reported rates varying widely from 5% to 50% due to heterogeneity in the definition and mode of diagnosis. PSHs are symptomatic in 75% of these patients, causing a significant impact on quality of life due to issues with appliance fitting, leakage, skin excoriation and pain. They can also lead to emergency presentations with strangulation and obstruction. Evidence is lacking on how to select patients for surgical intervention or conservative treatment. In those who do undergo surgery, the best operation for a particular patient or PSH is not always clear and many options exist. The aim of this study is to assess the impact of an individual patient's PSH treatment on their subsequent self-reported outcomes including treatment success and quality of life.

Methods: This is a prospective international cohort study of PSH treatment, including both operative and non-operative interventions. A global network of clinicians and specialist nurses will recruit 1000-1500 patients and centralize detailed information, their individual background and their PSH treatment, as well as short-term outcomes up to 30 days. Patients will then provide their own outcomes data including quality of life and whether their treatment was successful, via a secure online system, at 3, 6 and 12 months. PROPHER will be run in two phases: an internal pilot phase of at least 10 hospitals from up to five countries, and a main phase of up to 200 hospitals from across the European Society of Coloproctology network.

Discussion: This study will provide a wealth of contemporaneous information which will improve our ability to counsel patients and facilitate improved selection of appropriate and personalized interventions for those with a PSH.