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

Pere Planellas Giné

Status: Completed

Conditions: Sigmoid Cancer; Colorectal Cancer

Treatments: Procedure: Conventional locoregional lymphadenectomy; Procedure: Complete mesocolon excision

Study type: Interventional

Funder types: Other

Identifiers

NCT03083951

13117

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Complete Mesocolon Excision

Experimental group

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.

Treatment:

Procedure: Complete mesocolon excision

Conventional Locoregional Lymphadenectomy

Active Comparator group

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.

Treatment:

Procedure: Conventional locoregional lymphadenectomy