NCT05230329Not yet recruiting
CME Versus Standard Right Hemicolectomy for Right Sided Cancers
Source: ClinicalTrials.gov · Last updated 8 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 330 (estimated)
- First submitted
- 24 Jan 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Odense University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05230329
What you commit to
- Study type: Observational
- Planned participants: 330
- From 1 Mar 2022 to the primary completion date, 1 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Evidence of T4 disease invading adjacent organs
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Issam al-Najami Coordinator of this site? Confirm its status | Svendborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.