Rectal adenocarcinoma Cancer Rectal adenocarcinoma
Conditions
Interventions
Patients will be identified at local colorectal Multi-Disciplinary Team meetings and outpatient clinics. Potentially eligible patients will be approached by GCP (Good Clinical Practice) trained staff
Sponsors
Yeovil District Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with adenocarcinoma of the rectum (<15cm from anal verge as measured by staging MRI ) 2. Scheduled to undergo elective laparoscopic TME/ partial mesorectal excision surgery with curative intent, with or without neo-adjuvant treatment and with or without defunctioning stoma formation 3. Written informed patient consent
Exclusion criteria
Exclusion criteria: 1. History of inflammatory bowel disease 2. Patients requiring abdomino-perineal excision or surgery without anastomosis 3. Advanced tumours involving adjacent organs (TNM5 T4aNxMx) 4. Surgery performed with palliative intent or under unplanned/emergency settings 5. Previous treatment (radiotherapy/abdominopelvic surgery) for endometrial, ovarian, prostate, bladder (TURBT ok), anal or vaginal cancer 6. Patient or surgeon refusal to enter study or accept randomisation result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of technical errors during each operation. Each operation will be digitally recorded and analysed unedited by a blinded assessor using Objective Clinical Human Reliability Analysis (OCHRA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total operating time 2. Operative blood loss 3. Conversion to open surgery 4. Postoperative length of stay 5. 30 day readmission 6. Histological outcomes, including mesorectal specimen quality, which will be assessed by a pathologist using standardised criteria 7. Postoperative complications using the Clavien-Dindo classification 8. 30 day mortality 9. Surgeon-reported feedback on the adverse effects of the imaging system will also be recorded such as blurred vision, altered vision, light headedness and or dizziness 10. Surgeon-reported cognitive load assessment All complications occurring in hospital (index stay or re-admission) will be recorded up to 30 days. | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactNader Francis
Outcome results
None listed