Clinical trial · Interventional
Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer
Complete Mesocolic Excision (CME) With Central Supplying Vessel Ligation (CVL) Compared With Conventional Surgery for Colon Cancer: a Double-blinded Randomized Study
NCT02526836CI-TRIAL-00034402unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to compare between complete mesocolic excision with central vascular ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes, surgical outcome and complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete mesocolic excision with central vascular ligation | Procedure | — | UNRESOLVED |
| Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Comparison group
- description
- including the number of cases with complete data who underwent surgery using the conventional method. Conventional surgery
- interventionNames
- Procedure: Conventional Surgery
- type
- ACTIVE_COMPARATOR
- label
- Intervention group
- description
- including a convenient sample of about 20 patients which is expected to be recruited, for whom Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) will be done. Complete mesocolic excision with central vascular ligation
- interventionNames
- Procedure: Complete mesocolic excision with central vascular ligation
Primary outcomes (1)
- measure
- Lymph nodes harvest
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven adenocarcinoma (including mucinous and signet-ring cell) or adenosquamous carcinoma on endoscopic biopsy. * Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging \[barium enema or computed tomography (CT)\] without location of the lower border of the tumor at the rectum. * No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease. * Body mass index ≤ 35. * Sufficient organ function including cardiovascular system and liver. * Written informed consent. Exclusion Criteria: * Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment. * Infectious disease requiring treatment. * Body temperature ≥ 38 °C. * Pregnant women. * History of psychiatric disease. * Use of systemic steroids. * History of myocardial infarction or unstable angina pectoris within 6 months. * Severe pulmonary emphysema or pulmonary fibrosis
References
Publications (2)
- BACKGROUNDHohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5. PMID 19016817
- BACKGROUNDBertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31. PMID 25555421