BIOPEX follow-up study

  • Research type

    Research Study

  • Full title

    Long term outcome of biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer

  • IRAS ID

    234358

  • Contact name

    Baljit Singh

  • Contact email

    bs143@le.ac.uk

  • Sponsor organisation

    University Hospitals Leicester

  • Clinicaltrials.gov Identifier

    NCT01927497

  • Clinicaltrials.gov Identifier

    NTR3717, www.trialregister.nl

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    This study is to look at the long-term follow-up of patients that had taken part in the BIOPEX trial. In the BIOPEX trial patients underwent surgery for rectal cancer in which their anus was removed and they had a permanent stoma (bag). The defect left after removing the anus was either closed by existing tissue (primary tissue) or a biological mesh. The follow-up was only for one year.
    The current study is to follow-up the the trial patients for 5 years after surgery and see how they are with regard to their quality of life and whether they have developed any hernias following the surgery.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    18/NW/0111

  • Date of REC Opinion

    22 Mar 2018

  • REC opinion

    Further Information Favourable Opinion