Minimally Invasive Right Colectomy Anastomosis Study (MIRCAST)

  • Research type

    Research Study

  • Full title

    Minimally Invasive Right Colectomy Anastomosis Study (MIRCAST): A observational prospective multi-center 4-cohort study comparing robotic assisted and laparoscopic minimally invasive right colectomy, and intracorporeal anastomosis versus extracorporeal anastomosis

  • IRAS ID

    255052

  • Contact name

    Jim Khan

  • Contact email

    jim.khan@porthosp.nhs.uk

  • Sponsor organisation

    Fundacion Instituto de Investigación Marqués de Valdecilla (IDIVAL)

  • Clinicaltrials.gov Identifier

    NCT03650517

  • Duration of Study in the UK

    3 years, 4 months, 1 days

  • Research summary

    Surgical removal of the right side of the large bowel or colon is performed for the presence of a tumour in that part of the colon. Most of these right sided bowel resections (also called right hemicolectomy) nowadays are performed with keyhole surgery. The advantage of keyhole surgery (also called laparoscopic or minimal invasive) over open surgery is a quicker recovery, shorter hospital stay, less blood loss and less complications. Recently another type of keyhole surgery was introduced, the robotic keyhole surgery, which makes use of the Da Vinci robot. However, whether robotic assisted surgery is advantageous for this type of surgery compared to laparoscopy is still unclear.
    In addition to that, there are some studies that report better results with an intracorporeal anastomosis. An anastomosis is the connection between the two ends of the bowel which are reconnected after taking a part of the bowel out. The connection can either be made inside the abdomen with the keyhole instruments (intracorporeal), or outside the abdomen (extracorporeal). In this study we would like to compare robotic with laparoscopic right sided colectomy in combination with either an intracorporeal or an extracorporeal anastomosis in terms of infection rate at the site where the small incisions were made, the postoperative complications and the development of hernia’s post-surgery.
    The study will seek to recruit at least 1200 subjects (300 per group) throughout Europe, with 13 participating hospitals in the UK. The clinical data will be recovered from patients medical files. All patient operations and assessments will be done according to the sites standard of care. Quality of life will also be monitored with validated questionnaires. The total duration of the study will be 4 years. Data will be collected preoperative, at 30 days post-surgery, 3 months post-surgery, and at 1 and 2 years post-surgery.

  • REC name

    London - Camberwell St Giles Research Ethics Committee

  • REC reference

    19/LO/1519

  • Date of REC Opinion

    24 Jan 2020

  • REC opinion

    Further Information Favourable Opinion