Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5–8-year follow-up of the ROCSS randomized controlled trial
Authors:   Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and West Midlands Research Collaborative, Monahan Mark , Kaur Manjinder , Roberts Tracy , Munetsi Lorraine R , Jerome Ellen , Magill Laura , Evans Ruth , Mackay Siobhan , Popplewell Mathew , Ball Alasdair , Griggs Rebecca , Shabbir Jamshed , Ebrahim Ahmed , Hammond Toby , Ramesh Vibha , Amarnath Talakalukoppa , O’Connor Olivia , Tokidis Evripidis , Pierson Michael , Webster Peter , Wilson Tim , Davis George , Doyle Mark , Finch Benjamin , Gupta Anuj , Hill Denise , Popoola Michael , Rees Andrew , Santos Lisa , Stubbs Benjamin , Taylor Maddy , Bhatta Gakul , Liao Christopher , Rankin Adeline , Wilhelmsen Elva , Blackwell James , Lenzi Elisa , Watson Nicholas , Cooke Jill , Hardy Chloe , Runau Franscois , Wolff James , Amir Farhat , Hill Phillippa , Smart Chris J , Gates Zoe , Yassin Nuha , Holdsworth Rosie , Mishra Ami , Rabie Mohamed , Netherton Kimberley , Rao Milind , Walsh Adam , Bandyopadhyay Dibyendu , Barr Christopher , Kell Kay , Tulwin Agnieszka , Pippard Lucy , Mehta Samir , Glasbey James , Jowett Sue , Morton Dion , Pinkney Thomas , Handley Kelly , Brown James , Wilkin Richard , Bhangu Aneel , Asour Amani , Mangam Sudhakar , Acheson Austin , Ng James , Seehra Jaspreet , Elhakim Hersham , Watson Angus , Paraoan Marius , Singh Amal , Williams Claire , Lefroy Rebecca , Yeomans Neil , Katebe Joyce , Wales Emily , Zeolla Julian , Branagan Graham , Shaw Alistair , West Charles , Colley Julie , Saeed Samerah , Torrance Andrew , Antoniou Anthony , Baden Manisha , Baird Yolanda , Levy Bruce , Siddall Erikka , Sunny Ankita , Thirwall Yvette , Towner Ester , Ghods Manijeh , Hopkins Bridget , Karandikar Sharad , Mann Harvi , Whitehouse Arlo , Willis Healther , Ahmed Marriam , Ball Alasdair , Patel Abhilasha , Rayer Jessica , Williams Nigel , Baker Elizabeth , Wilson Deborah , Nicol Deborah , Duff Sarah , Kumarendran Mary , Pearson Iona , Francis Nader 
Published: August 2024

Abstract

Background
The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5–8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall–specific quality of life score.

Methods
Eligible participants from original UK centres were identified. The primary outcome (abdominal wall–specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients’ original allocation, even if the patient was aware of their treatment.

Results
Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (−2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04).

Conclusions
ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall–specific quality of life 5–8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on.

Trial Registration
ISRCTN25584182 (http://www.clinicaltrials.gov).