The role of 3D laparoscopic rectal surgery: a randomised controlled trial

ISRCTN	ISRCTN59485808
DOI	https://doi.org/10.1186/ISRCTN59485808
Secondary identifying numbers	N/A

Submission date: 09/12/2015
Registration date: 16/12/2015
Last edited: 10/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-to-improve-keyhole-surgery-for-rectal-cancer

Contact information

Mr Nader Francis
Public

Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom

Mr Nathan Curtis
Scientific

Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom

Study information

Study design	Multicentre randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	2D vs. 3D laparoscopic anterior resection: a randomised controlled trial
Study objectives	Using 3D imaging reduces intra-operative technical errors enacted during laparoscopic anterior resection.
Ethics approval(s)	South Central Berkshire B Research Ethics Committee, 24/02/2016, ref: 16/SC/0118
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	01/01/2015
Completion date	30/04/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	72
Total final enrolment	88
Key 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
Key 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
Date of first enrolment	02/01/2016
Date of final enrolment	30/03/2018

Locations

Countries of recruitment

England
United Kingdom
Wales

Study participating centres

Yeovil District Hospital

Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Royal Surrey County Hospital

Egerton Road
Guildford
GU2 7XX
United Kingdom

Frimley Park Hospital

Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

University Hospital of Wales

Heath Park
Cardiff
CF14 4XW
United Kingdom

Queen Alexandra Hospital

Cosham
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Yeovil District Hospital NHS Foundation Trust
Hospital/treatment centre

Higher Kingston
Yeovil
BA21 4AT
England
United Kingdom

Phone	01935 475122
Email	joanna.allison@ydh.nhs.uk
Website	www.yeovil.nhs.uk
"ROR"	https://ror.org/00v5nyn36

Funders

Funder type

Industry

European Association of Endoscopic Surgeons

No information available

Karl Storz GmbH & Co

No information available

Results and Publications

Intention to publish date	01/01/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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.
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2019	13/03/2019	Yes	No
Plain English results			24/03/2021	No	Yes
Results article	Factors predicting operative difficulty	01/12/2019	10/01/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

10/01/2023: Publication reference added.
24/03/2021: CRUK link added to results (plain English)
13/03/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
22/01/2018: The following changes were made:
1. Recruitment end date was changed from 01/12/2017 to 30/03/2018.
2. Overall trial end date was changed from 01/01/2018 to 30/04/2018.
3. Publication plan (presentation dates) updated.
15/12/2016: Cancer Help UK lay summary link added.
24/11/2016: Internal review.
24/03/2016: Ethics approval information added.