Extended Follow-up of the ROCSS Trial

 

ROCSS-EX logo

Site Resources

Beginning ROCSS-EX at an existing ROCSS site

  1. Local approval to substantial amendment number 7 (02-Dec-2020) must be in place
  2. Site personnel documentation provided to Trial Office (either by email or via the online electronic training log - see Training section below)
  3. Confirmation from Trial Office activities can commence and database logins provided

Participation in ROCSS-EX is only open to sites that took part in the original ROCSS trial.

The summary of for R&D that may assist in early assessment of capacity to implement the amendment that introduces ROCSS-EX.

ROCSS-EX Study Training

ROCSS-EX Study Training is available as part of the ROCSS-EX Electronic Training Log in the form of a video presentation - please ensure you continue through the log pages to properly submit your record.

  • Training may be delivered directly by the Trial Office or local PI but completion still needs to be documented using the ROCSS-EX Electronic Training Log.
  • Download the slides from the training presentation.

CVs, GCP and delegation logs can also be uploaded to the ROCSS-EX Electronic Training Log if they are available when completing your record, otherwise please email these to the Trial Office.

ROCSS-EX delivery at a site

  • The of activities involved in ROCSS-EX are summarised in the ROCSS-EX Flowchart
  • The ROCSS-EX Telephone Script provides assistance to complete telephone consultations.
  • ROCSS-EX Database
    • Data is capture is by eCRF using the ROCSS-EX database, which is a REDCap based system. Access with be given to investigators listed on the delegation log who have completed GCP and study-training, and have provided a CV with a "work" email. Please contact the Trial Office to discuss access.
    • A User Guide provides information on how to navigate and use the database.
    • Paper versions of the eCRF can be used as worksheet to collate data ready for entry but these do not need to be sent to the Trial Office:

Other resources:

General information about ROCSS-EX

Research Question

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?

Aims

  1. 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.
  2. To determine if the intervention is cost-effective after 5-8 years.

Objectives

  • 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

Outcome measures

Primary:

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

Funding

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.