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Complete mesocolic excision vs. standard right hemicolectomy trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45051056
Enrollment
80
Registered
2016-08-24
Start date
2018-10-01
Completion date
Unknown
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right sided colonic adenocarcinoma Cancer Malignant neoplasm of colon

Interventions

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

Sponsors

Portsmouth Hospitals NHS Trust, UK
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026