TRIUMPh

• Research type

  Research Study

• Full title

  A Non-Randomized, Prospective, Open Label, Single-site Feasibility Trial for Real-time Identification of the Ureters with a Methylene Blue fluoroPhore

• IRAS ID

  244315

• Contact name

  Manish Chand

• Contact email

  m.chand@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2019/08/16, UCL Data Protection Registration

• Duration of Study in the UK

  0 years, 6 months, 28 days

• Research summary

  Background – During certain abdominal surgeries there is difficulty in finding the ureters, which act as a conduit for urine from the kidneys to the bladder. If they are sectioned during surgery this causes great suffering for the patient and increased costs for the hospital and the NHS. Even experienced surgeons are at risk of causing this dreaded complication. Methylene blue can emit a fluorescent signal and therefore highlight the ureters in real time during surgical procedures.
  A trial is necessary to evaluate the effectiveness of methylene blue fluorescence to identify the ureters during surgery. However, the feasibility of recruiting patients to such a trial is unknown.
  Methods – In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included. The feasibility of recruitment of these patients will be assessed using a screening log.
  Expected results – we expect to define the recruitment rate of the patient group of interest and to identify the causes for non recruitment

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  19/LO/1769

• Date of REC Opinion

  12 Jan 2020

• REC opinion

  Further Information Favourable Opinion