Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)

Not Applicable

Completed

• Conditions: Sigmoid Cancer; Colorectal Cancer

• Registration Number: NCT03083951
• Lead Sponsor: Pere Planellas Giné

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Study Start: 2017-09-01
• Primary Completion: 2019-06-01
• Study Completion: 2023-01-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total number of lymph nodes and lymph node ratio.	30 days	To compare the total number of lymph nodes resected and the lymph node ratio (defined as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.

Secondary Outcome Measures

Name	Time	Method
Local recurrence	5 years	To compare the tumor local recurrence rate between the two arms.
Survival	5 years	To compare the survival rate (deaths from cancer) between the two arms

Trial Locations

Locations (1)

University Hospital Dr. Josep Trueta of Girona; 🇪🇸 Girona, Spain