CME Versus Standard Right Hemicolectomy for Right Sided Cancers
1 other identifier
observational
330
1 country
1
Brief Summary
Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME. Trial Title CME versus standard right hemicolectomy for right sided cancers Internal ref. no. Clinical Phase Trial Design Observational, prospective, international, multi-center study Trial sites 10 sites over 5 different countries Planned Sample Size At least 330 subjects will be enrolled in this study per cohort, including 10% of lost to follow-up patients). All patients during the enrolment period shall be screened and recorded at sites in order to identify any selection bias Treatment duration 3 years Follow up duration 5 years Planned Trial Period 10 years Objectives Outcome Measures Primary To compare the lymph node yield between complete mesocolic excision versus standard right hemicolectomy for patients with right sided cancer Number of harvested lymph nodes Secondary Incidence of local recurrence after surgery at 2 and 5 years Disease free survival (2 and 5 years) 5-year overall survival 30-day and 90-day mortality, 60-day postoperative major complications (As measured by the Comprehensive Complication Index (CCI®).) Pathological quality assessment. Completeness of mesocolon excision (CME) will be assessed by the pathologist Operative length of time (total OR utilisation time and operative time skin to skin, minutes) Assessment of intraoperative adverse events within advanced minimally-invasive surgery in order to report "near misses" and associated impact upon clinical outcomes Conversion to open surgery For Minimally invasive CME or standard right hemicolectomy - to compare the types of anastomosis (intra-corporeal versus Extra-coporeal ) on anastomosis leak rate 4. 5. 6. 7. Recurrence picked up on intensive follow up schedules with yearly CT scan for 5 years Definitions: Distal resected margin ≥ 5cm Lymph node yield Mesocolic plane of surgery Central vascular ligation (within 1cm of ileocolic vessels origins) R0 resection (all margins clear) Investigational Medicinal Product(s) n/a Formulation, Dose, Route of Administration n/a
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
ExpectedFebruary 8, 2022
February 1, 2022
3.9 years
January 24, 2022
February 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
we will assess the Number of harvested lymph nodes after colonic resectio
The primary aim of the study is to compare the lymph node yield between CME and standard right hemicolectomy in right sided cancers
3 years anticipated
Secondary Outcomes (9)
mortality and morbidity
90 days
Pathological quality assessment
90 days
Incidence of local recurrence after surgery at 1,3 and 5 years
5 years
Overall survival at 5 and 10 years
10 years
Assessment of intraoperative adverse events of the surgery
90 days
- +4 more secondary outcomes
Study Arms (3)
Completemesocolic excision by laparoscopy for right sided cancer
Completemesocolic excision by robot for right sided cancer
Standard right hemi colectomy excision by laparoscopy for right sided cancer
Interventions
Comparison of CME
Eligibility Criteria
Participants with right sided cancer who are scheduled for initial treatment by either CME or standard right hemicolectomy
You may qualify if:
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Undergoing CME or standard right hemicolectomy surgery for right-sided cancer after MDT discussion.
- Cancer must be confirmed by histological, radiological, endoscopic diagnosis
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
You may not qualify if:
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Participant with life expectancy of less than 6 months.
- Distal Transverse colon and splenic flexure tumors
- Evidence of T4 disease invading adjacent organs
- Synchronous surgical procedure planned with CME or right hemicolectomy
- Urgent, unplanned or emergency surgery
- Neoadjuvant chemotherapy administered to treat this cancer prior to resection
- Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality
- Known Crohn's disease with active terminal ileal disease
- Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation).
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Issam al-Najami
Svendborg, Southern Denmark, 5700, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Issam Al-Najami, M.D Ph.D.
Odense University hospital, department of colorectal surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 24, 2022
First Posted
February 8, 2022
Study Start
March 1, 2022
Primary Completion
February 1, 2026
Study Completion (Estimated)
February 1, 2028
Last Updated
February 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share