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The PROPHER study: Patient Reported Outcomes after Parastomal Hernia treatment – a prospective international cohort study
Professor Thomas Pinkney
A significant proportion of stoma patients develop a parastomal hernia (PSH), with reported rates varying widely from 5% to 50%. 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 bowel strangulation and obstruction.
There remains a pressing need to establish the best treatment of PSH. In particular, it is not always clear which patients should undergo surgical repair, and in those who do, the best technique of repair is yet to be established. There is wide variability in surgical behaviour when treating PSH, including aspects such as whether a mesh is used to reinforce the repair, and the optimum mesh material, trephine size and shape and plane of placement.
Specific and/or new techniques have been published in small series by enthusiasts with promising results, but overall outcomes after surgical repair remain disappointing. The same challenges encountered with the initial definition and diagnosis of PSH also cause issues when trying to assess whether an intervention to treat PSH has been successful.
We propose a unique prospective international cohort study of PSH treatment, including both operative and non-operative interventions.
This will utilise our existing global network of surgeons to obtain detailed information on the exact interventions used and short-term outcomes, then empower patients to provide their own medium and long-term outcomes data and to report whether their treatment was successful. This will provide a wealth of information that will improve our ability to counsel patients and facilitate improved selection of appropriate and personalised interventions for those with a PSH.
The team plan to:
- audit parastomal hernia treatment, including rates of surgical intervention at participating centres, operative techniques employed and short term (30 day) post-operative outcomes
- ascertain the outcomes and impact on Quality of Life of patients undergoing parastomal hernia repair
- ascertain the outcomes and impact on Quality of Life of patients who opt for watchful waiting
All patients over the age of 18 who are seen at, or referred to, a participating site for consideration of PSH treatment will be eligible for the study. We will capture data from patients both undergoing surgical intervention and having conservative treatment/watchful waiting, using the same follow-up tools. It is anticipated that some patients will pass from the conservative group to undergo operative intervention during the lifetime of the study; this information will also be captured.
After an international internal pilot/feasibility phase (6 months; 20-25 sites; 5 countries) to verify acceptability, patient pathways, and early retention as well as testing data collection systems, we will proceed to the main phase of the study. This will open to all interested sites globally, via colorectal surgery societies, specialist hernia associations and stoma care nursing societies. Our initial primary target group will be our network of sites who have already participated in prospective patient-level audits.
£55,975 funded by IA