Incisional hernia Surgery
Conditions
Interventions
There is no intervention if ROCSS-EX as such as it extended follow-up – the intervention under investigation remains the same one as in the original ROCSS trial (Reinforcement of the stoma closure sit
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants included in the ROCSS trial are eligible to be included in ROCSS-EX unless they withdrew or did not have their stoma reversed during the duration of the original trial. those participants who have died, only routinely collected data will be used.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life at 5 to 8 years following closure of stoma site comparing participants who had mesh reinforcement of their abdominal wall with participants that had a standard closure. This will be assessed using the HerQLes tool | — |
Secondary
| Measure | Time frame |
|---|---|
| At 5-8 years follow-up: 1. Participant reported incisional hernia rate 2. Number of hospital visits for any hernia related reason 3. Number of interventional procedures related to the stoma closure site or hernia 4. Longitudinal QoL assessed using EQ-5D 5. Cost analysis for all additional hernia related events | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactJames Brown
Outcome results
None listed