Surgical Quality Assurance in COLOR III Trial

• Research type

  Research Study

• Full title

  Surgical Quality Assurance in COLOR III Trial

• IRAS ID

  181324

• Contact name

  George Hanna

• Contact email

  g.hanna@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  5 years, 0 months, 6 days

• Research summary

  COLOR III Trial is a randomised clinical trial that involves many centres in Europe and some in the USA. It is to evaluate the benefit of transanal total mesorectal exiciosn (TaTME), i.e resecting the rectal cancer tumour through the anus (bottom up approach), comparing to the traditional key hole surgery i.e resecting through the abdomen.

  TaTME is an innovative operation and also technically demanding; it involves new skills, such as operating through a small tunnel. Within the COLOR III trial, it is crucial to ensure that the participating surgeons perform TaTME at an agreed standard. Therefore, this study aims to develop a robust Surgical Quality Assurance (SQA) system.

  The 3 objectives are:

  1. Standardising the TaTME technique.
  Experts’ opinions will be sought to reach a consensus on mandatory surgical stages and steps of TaTME. The methods used are Delphi methodology and Hierarchical task analysis. Delphi methodology has been used to generate consensus between experts via semi-structured interviews and questionnaires, commonly seen in policy making. It seeks the opinions of individuals and exchanges feedbacks in multiple rounds to in order to reach an agreement. Hierarchical task analysis is used to break down a task or in the case, an operation into stages and steps; this will be used in conjunction with Delphi methodology to describe and standardise TaTME.

  2. Developing operation manual and competency assessment tool (CAT).
  The mandatory steps will be used to write an operation manual and develop a scoring sheet to assess surgeon’s competency (CAT) is performing TaTME . CAT will be tested for usability, reliability and validity.

  3. Assessment before trial entry and during the trial.
  Surgeons will be asked to submit 2 unedited videos before the trial entry, and 1 every 3 during the trial period. These videos will be assessed using the validated CAT tool.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  16/LO/1591

• Date of REC Opinion

  27 Sep 2016

• REC opinion

  Unfavourable Opinion