2D vs. 3D laparoscopic anterior resection: a randomised controlled trial
Rectal adenocarcinoma
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 with delegated responsibility at each centre, who will discuss the study with the patient and answer any questions. Patients will be given a written site specific participant information sheet to take away. If willing and eligibility is confirmed, written consent will be obtained and the patient randomised. All trial participating centres and trial surgeons are experienced in using 3D imaging systems. Centralised randomisation will take place at Yeovil Hospital Clinical Research Unit. Allocation into one of two groups will be determined using pre-prepared computerised random number generation (zero or one) to allocate in a 1:1 ratio: 1. Group 1 patients undergo laparoscopic anterior resection using a 2D imaging system. 2. Group 2 patients undergo laparoscopic anterior resection using a 3D imaging system.
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
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