Clinical trial · Interventional
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
NCT03083951CI-TRIAL-00070099CMELLcompletedN/AClinicalTrials.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)
A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Sigmoid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete mesocolon excision | Procedure | — | UNRESOLVED |
| Conventional locoregional lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Complete Mesocolon Excision
- description
- A high tie of the inferior mesenteric artery (IMA) should be attempted. The inferior mesenteric vein section at the Treitz angle should be performed. The lymphatic tissue that accompanies the inferior mesenteric vein should be added.
- interventionNames
- Procedure: Complete mesocolon excision
- type
- ACTIVE_COMPARATOR
- label
- Conventional Locoregional Lymphadenectomy
- description
- A high tie of the inferior mesenteric artery (IMA) should be attempted. Lymphadenectomy of the lymphatic tissue that accompanies the IMA will be performed. The inferior mesenteric vein section could be performed at the discretion of the surgeon.
- interventionNames
- Procedure: Conventional locoregional lymphadenectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer. * Age ≥ 18 years and \<80 years. * Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy. * Any T, any N, M0. * Intention of resection R0. * Informed consent signed by the patient and the investigator. Exclusion Criteria: * Colorectal tumor with histology other than adenocarcinoma or adenoma. * Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon. * Metastatic disease (M1). * History of colorectal cancer surgery, different from a local excision. * Inflammatory bowel disease with anatomopathological confirmation. * Patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent. * Inability to read or understand any of the languages of the informed consent (Catalan, Spanish). * Another synchronous malignant disease. * Emergency surgery.
References
Publications (2)
- DERIVEDPlanellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Impact on defecatory, urinary and sexual function after high-tie sigmoidectomy: a post-hoc analysis of a multicenter randomized controlled trial comparing extended versus standard complete mesocolon excision. Langenbecks Arch Surg. 2023 Aug 1;408(1):293. doi: 10.1007/s00423-023-03026-9. PMID 37526748
- DERIVEDPlanellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Extended Versus Standard Complete Mesocolon Excision in Sigmoid Colon Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2022 Feb 1;275(2):271-280. doi: 10.1097/SLA.0000000000005161. PMID 34417367