Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
2D vs. 3D laparoscopic anterior resection: a randomised controlled trial
Acronym
Study hypothesis
Using 3D imaging reduces intra-operative technical errors enacted during laparoscopic anterior resection.
Ethics approval
South Central Berkshire B Research Ethics Committee, 24/02/2016, ref: 16/SC/0118
Study design
Multicentre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Rectal adenocarcinoma
Intervention
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.
Intervention type
Device
Phase
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/01/2015
Overall trial end date
30/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72
Total final enrolment
88
Participant 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
Recruitment start date
02/01/2016
Recruitment end date
30/03/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Trial participating centre
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Trial participating centre
Frimley Park Hospital
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom
Trial participating centre
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Trial participating centre
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Organisation
Yeovil District Hospital NHS Foundation Trust
Sponsor details
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
01935 475122
joanna.allison@ydh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
European Association of Endoscopic Surgeons
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Karl Storz GmbH & Co
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The findings will be written up for publication in Surgical Endoscopy as per contract with the funding body (European Association of Endoscopic Surgery) and will be presented at EAES congress meeting in May 2018 and ACPGBI conference in July 2018. The outcome of this project would be described during educational events organised by the Clinical Research Unit, Yeovil.
Intention to publish date
01/01/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30656453 (added 13/03/2019)