Parastomal hernia (PSH) Digestive System
Conditions
Interventions
PROPHER is an international multi-centre prospective cohort study. A global network of clinicians and specialist nurses will enrol adults over the age of 18 years with a symptomatic parastomal hernia
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult, aged 18 years and above. 2. A stoma formed from any part of the bowel – whole small bowel and colon, and of any format – including loop, end, double barreled, Abcarian, other 3. All treatments for PSH, including conservative (non-operative) treatment and surgical intervention. All types of surgical approach are included. 4. Elective presentations to outpatient services, including surgical, colorectal, stoma care team are included. Patients presenting primarily as an emergency with a symptomatic PSH requiring urgent intervention are also eligible for inclusion, providing informed consent can be obtained.
Exclusion criteria
Exclusion criteria: 1. Patients with an isolated urostomy 2. Life expectancy less than 12 months 3. Proposed treatment plan for dealing with PSH involves restoration of gut continuity meaning that patient will have no stoma after treatment. 4. Anyone who does not have an email address or does not have access to the internet or a smart device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will collect a range of clinical and patient-reported outcome measures. There is no explicit primary outcome measure. Patient-reported outcomes: 1. Health-related quality of life reported by the participant using the SF-12 score at baseline and 3, 6 and 12 months post-enrolment 2. Stoma impact reported by the participant using the Stoma Impact Score at baseline and 3, 6 and 12 months post-enrolment 3. Impact of the key symptom or issue the patient is hoping will be improved by their PSH treatment assessed using the modified Measure Yourself Medical Outcomes Profile (MYMOP) at baseline and 12 months post-enrolment 4. Decisional regret assessed using the Decision Regret Scale at 12 months post-enrolment Clinician-reported outcomes based on routinely collected data held in patient notes transcribed into electronic case report forms (eCRFs): 1. Patient demographics – including BMI, smoking status and comorbidities assessed using the online case report form (CRF) for the study at baseline 2. PSH details - including index operation, PSH characteristics and symptoms, previous treatments for this PSH - assessed using the online CRF at baseline 3. In those undergoing surgical repair: 3.1. Operation details – including technique employed, type and location of mesh placement (if appropriate) assessed using the online CRF at time of surgery 3.2. Short-term post-operation details assessed using the online CRF up to 30 days post-surgery, including: 3.2.1. Postoperative complications assessed using the Clavien-Dindo Scale 3.2.2. Postoperative complications assessed using the comprehensive complication index (CCI) 3.2.3. Length of stay 3.2.4. Unplanned re-operation 4. In those undergoing non-operative management: 4.1. Details of conservative treatment instigated, including support wear, physiotherapy, other advice given assessed using the online CRF at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no additional outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed