The PROPHER Study: Patient reported outcomes after parastomal hernia treatment

ABSTRACT

Purpose/Background: The reported rates of stoma patients who develop a parastomal hernia (PSH) are between 5% to 50%. PSHs are symptomatic in 75% of these patients, causing a significant impact on quality of life. There remains a pressing need to establish the optimum treatment of PSH. We don't know if PSH repair improves patients QoL as it's not something that has been reliably looked at in previous PSH studies. of the eleven studies published between 2004 and 2017 only two included QoL. Fleshman (2014) used the Stoma QoL questionnaire, and Brandsma (2017) used SF36 and EQ5D. The problem with these tools is that SF36 and EQ5D are generic health status, and Stoma QoL covers generic stoma problems, and is not PSH specific. PROPHER is a prospective international cohort study of PSH treatment. The primary aim is to explore differences in surgical techniques, outcomes and QoL across operated and non-operated patients with PSH to identify areas of variability, and whether this results in differences in outcomes and impact on patients QoL that would warrant further study. Methods/Interventions: All patients over the age of 18 with a bowel stoma who are referred for consideration of PSH treatment will be eligible to enrol in the study. We will capture data from patients undergoing surgical intervention and having conservative treatment. For patients who undergo a surgical repair, we will record data on surgical techniques, mesh, and postoperative complications. We will also capture QoL data for both cohorts of patients. PROMS are a primary outcome measure in PROPHER. We will be utilising novel technology to complete the patient follow up, with the use of a mobile phone app, which will send notifications to the patients to complete the questionnaires. The patient reported outcomes will include re-admission, re-intervention, quality of life, PSH specific symptoms, and decisional regret. PROPHER is also the first colorectal study to use MYMOP (Measure Yourself Medical Outcomes Profile), a patient generated outcome measure questionnaire. Results/Outcomes: PROPHER will open for recruitment in September 2021, having been delayed due to the COVID19 pandemic. By the time of the Tripartite meeting we will have the first 6 months of data on patients entered into the study. of particular interest will be the baseline MYMOP data, allowing us to fully understand the decision drivers for patients undergoing parastomal hernia treatment. Conclusion/Discussion: PROPHER will provide a wealth of contemporaneous information that will improve our ability to counsel patients and facilitate improved selection of appropriate and personalised interventions for those with a PSH.