Condition category
Cancer
Date applied
09/12/2015
Date assigned
16/12/2015
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Mr Nader Francis

ORCID ID

Contact details

Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom

Type

Scientific

Additional contact

Mr Nathan Curtis

ORCID ID

Contact details

Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom

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 measures

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

01/01/2018

Reason abandoned

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

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

01/12/2017

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

www.yeovil.nhs.uk

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 meetings. 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review. 24/03/2016: Ethics approval information added.