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CME Versus Standard Right Hemicolectomy for Right Sided Cancers

NCT05230329 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2022-02-08

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

right sided hemicolectomy, laparoscopy

Comparison of CME

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Issam Al-Najami, M.D Ph.D. · Odense University hospital, department of colorectal surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2026-02-01
Completion
2028-02-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230329 on ClinicalTrials.gov