Complete mesocolic excision vs. standard right hemicolectomy trial

Not Applicable

• Conditions: Right sided colonic adenocarcinoma; Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN45051056
• Lead Sponsor: Portsmouth Hospitals NHS Trust, UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-24
• Study Completion: 2019-05-31
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Size of resection specimen<br> 2. Number of lymph nodes present<br>

Secondary Outcome Measures

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