ROCSS trial

ROCSS: Reinforcement of Closure of Stoma Site. A randomised controlled trial of reinforcement of closure of stoma site using a biological mesh.

ROCSS is a randomised controlled trial assessing the placement of biological mesh in order to reduce the rate of hernias at the site of stoma closure. Strattice is a well-established biological mesh/ tissue matrix which would be compared against a control arm of no mesh placement.

The Rationale for a Trial

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 is 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.

Trial Design

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

ROCSS is 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 is 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 aims to randomise 560 patients in 2 years. The end date for recruitment is 31-May-2015 with trial follow-up being completed in summer 2017.

UPDATE: Recruitment has been extedned until 30-Sep-2015 with the aim of increasing the sample size to 790 as recruiment is going so strongly. This will increase the statistical power from 80% to 90%.

Feasibility Study

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 proces
  • 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.

Trial Objectives

 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

ROCSS Trial Surgical Technique

 

Trial Outcome Measures

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

Randomisation

To randomise a patient please call 0800 953 0274 or log into:

https://www.trials.bham.ac.uk/ROCSS

If you do not have log in details please contact the ROCSS office who will be able to provide these.

ROCSS Study Office

Email: rocss@trials.bham.ac.uk

James Brown (Trial Coordinator) Tel: 0121 415 9965 Email: j.p.brown.1@bham.ac.uk

Mike Walters (Data Manager) Tel: 0121 415 9965 Email: m.walters@bham.ac.uk

Laura Magill (Trials Team Leader) Tel: 0121 415 9105 Email: e.l.magill@bham.ac.uk

 

NewROCSSLogo

 

REC West Midlands, Coventry and Warwickshire: 12/WM/0187

 

ISRCTN46330337

 

ROCSS Trial Protocol (Version 5.0 Date 01Jun2015)

 

Contact the ROCSS Team