Condition category
Cancer
Date applied
17/08/2016
Date assigned
24/08/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Mr Manish Chand

ORCID ID

Contact details

University College London Hospitals NHS Foundation Trust
London
NW1 2BU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.0

Study information

Scientific title

COmplete Mesocolic Excision vs. standard of care right hemicolectomy randomised controlled Trial

Acronym

COMET

Study hypothesis

Complete mesocolic excision and central vascular ligation results in a larger specimen with more lymph nodes than standard of care right hemicolectomy surgery

Ethics approval

Not provided at time of registration

Study design

Multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Right sided colonic adenocarcinoma

Intervention

Intervention - CME/CVL right hemicolectomy
Control - standard of care right hemicolectomy

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Size of resection specimen
2. Number of lymph nodes present

Secondary outcome measures

1. Operative time (minutes, intraoperative)
2. Blood loss (ml, intraoperative - swab weight and suction volume)
3. Length of hospital stay (postoperative days)
4. Early morbidity (30 day postoperative complications, Clavien-Dindo Classification, prospective observational recording from case notes and clinical team)
5. Surgical technique (open, laparoscopic or robotic, size of specimen, number of lymph nodes and above secondary outcomes)
6. Three year disease free and overall survival (observational recording from MDT records)
7. Specimens not compatible with CME/CVL surgery (Histopathological and/or operative video assessment - interventional arm only)
8. Extent of standard of care right hemicolectomy surgery (specimen size and number of lymph nodes, post-operative histopathological assessment)

Overall trial start date

02/01/2017

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18+ years
2. Provision of written informed consent
3. Biopsy proven colonic adenocarcinoma located proximal to the mid transverse colon
4. Acceptable clear distal margin possible without division of the middle colic vessels
5. Local MDT recommends right hemicolectomy
6. Treatment undertaken with curative intent
7. Elective/scheduled operation
8. Patient assessed as fit for surgery
9. Minimal staging investigations performed - CT chest/abdomen/pelvis and full colonic assessment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Patient refusal
2. Any neoadjuvant treatment (including stenting)
3. Treatment undertaken with palliative intent
4. Emergency surgery (unplanned resection within 48hrs of admission)
5. More extensive colonic resection surgery required or performed (extended right hemicolectomy - division of all middle colic vessels, subtotal colectomy)
6. R1/R2 on histopathological assessment

Recruitment start date

01/04/2017

Recruitment end date

01/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

St Mark's Hospital
Northwick Park, Watford Road, Harrow
London
HA1 3UJ
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
St James’s University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Joint Research Office, University College London

Sponsor details

UCL
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ucl.ac.uk/jro/index

Funders

Funder type

Not defined

Funder name

Pelican Cancer Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.