Introduction Hernia formation at the site of a previous stoma occurs in up to 30% of patients, 50% of whom are subject to complex re-operation. This paper reports the phase II randomised feasibility study of prophylactic reinforcement of closed stoma sites using biologic mesh, representing a novel surgical technique using a novel implantable device.
Method Multicentre, patient and assessor blinded, randomised controlled trial aiming to recruit 560 patients, delivered though trainee research collaboratives working within existing surgical networks. An initial internal feasibility study of 90 patients aimed to test early safety and deliverability of the surgical technique implemented across multiple sites simultaneously.
Results The feasibility study recruited 90 patients from 104 patients approached (92%), three months ahead of schedule. 90% of participating centres randomised patients within 30 days of opening. Overall, 41.1% of stomas were created for a malignant indication (versus benign, 37/90) and 73.3% were ileostomies (versus colostomy, 66/90). No mesh-specific complications were reported. One mesh was removed for access to the abdominal cavity, unrelated to the mesh itself. Independent Data Monitoring Ethics Committee review of un-blinded adverse event rates by allocation arm allowed no major safety concerns and allowed the feasibility study to progress into the full phase III trial.
Conclusion This feasibility report describes the early safety of biologic mesh placement within a novel surgical technique, paired with rapid, standardised delivery across a multicentre setting as part of a randomised trial. It shows that trainee research networks can lead and deliver complex interventional surgical trials, enabling progression to a full phase III study.
Disclosure of interest None Declared.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.