Coronary artery bypass grafting surgery: endoscopic vein harvesting Surgery
Conditions
Interventions
Hospitals will be randomised to use either the current keyhole training method or a structured keyhole training method using a cluster randomisation method (1:1 ratio of hospitals).
Current keyhole t
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Trainees: 1. All qualified surgical care practitioners with at least 12 months of experience in open vein harvesting but no previous experience on EVH techniques will be eligible to participate. SCPs with experience in EVH procedures will be excluded. 2. SCPs in the intervention arm must own a smartphone because MELT training includes improvement of hand-eye coordination (full details given in recruitment justification) using phone games like Temple Run and Teeter, with a screen capture of daily scores logged centrally for analysis. The games were selected for their hand-eye coordination content as there are no specific smartphone games specifically for improving endoscopic vein harvesting techniques. Please note that these applications are free for any smartphone download and there is no need for any personally identifiable details to be entered unless the trainee wants to add their name to keep a track of their game progress. Patients: 1. Patients aged over 18 years providing written informed consent to participate 2. Elective and urgent patients 3. Patients who need at least one length of long saphenous vein for surgery 4. Patients undergoing on-pump Coronary Artery Bypass Graft (CABG) surgery
Exclusion criteria
Exclusion criteria: Trainees: 1. Under 12 months qualified 2. Do not want to participate in this study 3. SCPs with experience in EVH procedure 4. SCPs who do not have a smartphone and are not willing to use their phone to play games Patients: 1. Patients undergoing emergency surgery 2. Patients undergoing off-pump CABG surgery 3. Contra-indication for endoscopic vein harvesting including varicosities of the long saphenous vein, small or thin legs (<7.5 cm diameter at the lower calf) or superficial Long Saphenous Vein (LSV) (less than 0.5 cm deep from the skin), determined using ultrasound scans 4. Patient with severe renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Long saphenous vein integrity, as indicated by the level of histological damage on endothelial, muscular, and adventitial layer measured using the following assessment of histological vein samples collected on the day of surgery: 1.1. A 0-3 scale for circular and longitudinal muscle layer (where 0 is normal and 3 is severe damage) 1.2. A score of 0 to 100% for muscle detachment measured using a validated scoring system using for immunohistological staining 1.3. A 0-4 scale for endothelial damage where (where 0 is normal and 4 is a complete loss of endothelial layer) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical Care Practitioner (SCP) anxiety levels measured using the Beck Anxiety Inventory scale, operator skills, and confidence during training and post-training 2. Patient satisfaction measured using a 100 mm visual analogue scale, with 100 mm indicating complete satisfaction of the leg wound before discharge from the hospital, and at 3 and 12 months 3. Post-surgical clinical outcomes including Major Adverse Cardiac Events (MACE): re-occurrence of angina, re-intervention, myocardial infarction, vein graft failure, stroke, and mortality measured using a telephone questionnaire at 1, 3, 6, 9, and 12 months 4. Wound assessment measured using vein scoring by consultant surgeons on the day of surgery 5. Wound complications measured using the Southampton modified asepsis score system until discharge and at 6 weeks 6. Cost-effectiveness analysis measured using the SF-36 and EQ-5D-5L quality of life questionnaires (incremental cost per QALY) pre-surgery, and at 3 and 12 months, and using telephone clinical MACE questionnaire to calculate the unit cost of all disposables and estate costs from admission until 12 months 7. Trainee satisfaction measured using the Learner Satisfaction Survey as part of Kirkpatrick learning tool (level 1 and 2) during training and post-training 8. Trainee technical skills measured using the Global Operative Assessment of Laparoscopic Skills (GOALS) scoring system during training and post-training | — |
Countries
England, United Kingdom
Outcome results
None listed