ROCSS trial

The results of the original ROCSS trial are published in the Lancet (volume 395, Issue 10222, P417-426, 08 February 2020); https://doi.org/10.1016/S0140-6736(19)32637-6

PRIMARY OUTCOME: Occurrence of clinically detected hernias at two years post closure

The clinically detectable hernia rate at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43–0·90; p=0·012).

 

Other ROCSS publications:

• Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative. Randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement: study protocol of the ROCSS trial. Colorectal Dis. 2018 Feb;20(2):O46-O54. doi: 10.1111/codi.13997
  

• Bhangu A, Futaba K, Patel A, Pinkney T, Morton D. Reinforcement of closure of stoma site using a biological mesh. Tech Coloproctol. 2014 Mar;18(3):305-8. doi: 10.1007/s10151-013-1001-3

Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernias. Use of biological meshes in these situations may provide a safe method of reducing these complications, especially long-term incisional hernias. ROCSS will use stoma site closure as a model for biological mesh placement during any difficult contaminated abdominal wall closures. 

Hernia at the site of stoma closure occurs in up to 30% of patients and is associated with adverse effects on quality of life. In up to 10% of cases, patients are submitted to complex re-operation which carries significant morbidity. Not all patients will report symptoms or undergo repair, as they do not wish to have a further major operation. Incisional hernias at the site of stomas closure form an important and well defined subgroup. If there is a measurable benefit from mesh insertion, elective use of a collagen mesh would warrant consideration in the closure of other difficult, contaminated abdominal wounds. This study will also provide useful information on the value of using a CT scan as an early diagnostic tool of herniation, which could then be used in future abdominal wall studies as a surrogate endpoint for clinical hernia.

The aim of the ROCSS trial was to assess whether a biological mesh (collagen tissue matrix) reduces the incidence of clinically detectable stoma closure site hernias at two years compared to standard closure techniques.

ROCSS was a prospective, multi-centre randomised controlled trial.

ROCSS was designed in two stages:

i)  a feasibility study

ii) a Phase III multi-centre RCT

The feasibility phase assessed recruitment, the randomisation process and deliverability of the treatment.

The Phase III study was a prospective, multi-centre RCT to determine if the use of a collagen tissue matrix (Strattice®) reduces the incidence of clinically detectable stoma closure site hernias at two years as compared to standard closure techniques.

The trial aimed to randomise 560 patients in 2 years with the end date for recruitment is 31-May-2015 and trial follow-up being completed in summer 2017. However, recruitment was extended to allow the sample size to be increased to 790 as recruitment is going so strongly. This increased the statistical power from 80% to 90%. Recruitment was competed o n 11-Nov-2015 and trial follow-up completed at the end of 2017.

The objectives of the feasibility study were:

• To develop strategies for effective recruitment and randomisation
• To assess the deliverability of the mesh placement technique

The outcome measures for the feasibility study were

• Recruitment
• Patient identification and randomisation process
• Deliverability and safety of technique for mesh placement

The feasibility study showed that patient recruitment and the randomisation process were feasible and that the technique to be used for reinforcement of the stoma closure site with the collagen mesh is deliverable. We have therefore run seamlessly on from the feasibility study with recruitment for the main full phase III trial. A publication relating to the feasibility study has been accepted by Colorectal Disease; Feasibility study from a randomised controlled trial of standard closure of stoma site versus biologic mesh reinforcement on behalf of the Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative (DOI: 10.1111/codi.13310).

 Primary objective:

• To assess whether a collagen tissue matrix (Strattice) reduces the incidence of clinically detected stoma closure site hernias at two years compared to standard closure techniques.

Secondary objectives:

To assess:

•  Frequency of wound infections and seroma associated with the mesh.
• Patient quality of life and pain experienced.
• Cost effectiveness of the mesh insertion in stoma site closure and management of subsequent hernias.
• Exploratory analysis to investigate the CT scan as an early surrogate marker of late clinical herniation:
• Radiological hernia rate at one year post closure will be compared with the clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of herniation

 

Primary outcomes:

•  Occurrence of clinically detected hernias at two years post closure

Secondary outcomes:

•  Radiological hernia rate at one year post closure. An exploratory analysis will compare radiological hernia rate at 1 year with clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of incisional hernias
• Surgical re-intervention rate
• Surgical complications at 30 days and 1 year
• Quality of life and post-operative pain
• Cost-benefit analysis

The ROCSS trial is funded by the following grants:

• ROCSS feasibility study was funded by LifeCell
• ROCSS trial was funded by the NIHR Research for Patient Benefit (RfPB) (ref. PB-PG-0416-20045)

 

Email: rocss@trials.bham.ac.uk 

 

Tel: +44 (0) 121 414 2779 (Ruth Evans - Trial Manager)

 

Tel: +44 (0)121 415 9104 (Manjinder Kaur - Trial Management Team Leader)

 

Address: ROCSS Trial Office, Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, Public Heath Building, University of Birmingham, Edgbaston, Birmingham B15 2TT

 

 

The Chief Investigator of the ROCSS trial is:

• Professor Dion Morton - Professor of Surgery; University Hospital Birmingham

Other key members of the Trial Management Group are:

• Professor Thomas Pinkney; University Hospital Birmingham
• Mr Aneel Bhangu; University Hospital Birmingham