Complete mesocolic excision vs. standard right hemicolectomy trial
| ISRCTN | ISRCTN45051056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45051056 |
| Protocol serial number | v1.0 |
| Sponsor | Portsmouth Hospitals NHS Trust, UK |
| Funder | Pelican Cancer Foundation |
- Submission date
- 17/08/2016
- Registration date
- 24/08/2016
- Last edited
- 30/12/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jim Khan
Scientific
Scientific
Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Scientific title | COmplete Mesocolic Excision vs. standard of care right hemicolectomy randomised controlled Trial |
| Study acronym | COMET |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Right sided colonic adenocarcinoma |
| Intervention | Intervention - CME/CVL right hemicolectomy Control - standard of care right hemicolectomy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | 1. Size of resection specimen 2. Number of lymph nodes present |
| Key secondary outcome measure(s) | 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) |
| Completion date | 31/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 01/05/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
University College London Hospitals NHS Foundation Trust
235 Euston Road
London
NW1 2BU
United Kingdom
London
NW1 2BU
United Kingdom
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
St Mark's Hospital
Northwick Park, Watford Road, Harrow
London
HA1 3UJ
United Kingdom
London
HA1 3UJ
United Kingdom
Leeds Teaching Hospitals NHS Trust
St James’s University Hospital
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Portsmouth Hospitals NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Editorial Notes
30/12/2021: The trial was stopped.
08/11/2019: Internal review.
05/08/2019: Internal review.
21/06/2019: Internal review.
05/04/2019: Internal review.
05/03/2019: Internal review.
20/02/2019: The sponsor of the trial has been changed from Joint Research Office, University College London to Portsmouth Hospitals NHS Trust, UK
19/02/2019: Internal review.
20/06/2018: The following changes have been made:
1. The recruitment start date has been changed from 01/04/2017 to 01/10/2018.
2. Portsmouth Hospital NHS Trust has been added to the trial centres.
07/06/2018: Internal review.
14/05/2018: Internal review.
16/01/2018: Internal review.
31/10/2017: Internal review.
