Is there a significant improvement in long-term quality of life for patients that have a biological mesh reinforcement of the abdominal wall at the time of closure of stoma site, and is the intervention cost-effective?
- To investigate if the biological mesh closure group has a significant long-term improvement in participant quality of life 5-8 years after stoma reversal.
- To determine if the intervention is cost-effective after 5-8 years.
- To assess the long-term effects of mesh reinforcement of the abdominal wall at the time of stoma closure on quality of life
- To assess the participant reported incisional hernia rate
- To report the number of hernia related hospital visits
- To report the number of interventional procedures related to the stoma closure site or any subsequent hernia
- To explore the long-term cost effectiveness of mesh reinforcement
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 tool17,18.
Secondary: (all at 5-8 years follow-up)
- Participant reported incisional hernia rate
- Number of hospital visits for any hernia related reason
- Number of interventional procedures related to the stoma closure site or hernia
- Longitudinal QoL assessed using EQ-5D
- Cost analysis for all additional hernia related events
ROCSS-EX is funded by the NIHR Research for Patient Benefit (RfPB) (NIHR202011). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.