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

Colorectal Cancer Clinical Trial

— CMELL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083951
• Other study ID #: 13117
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2023
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 1, 2023
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Sigmoid Cancer
• Sigmoid Neoplasms

Intervention

Procedure:
• Complete mesocolon excision
Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision)
• Conventional locoregional lymphadenectomy
Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.

Locations

Country	Name	City	State
Spain	University Hospital Dr. Josep Trueta of Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Pere Planellas Giné

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications	Postoperative complications within 90 days after surgery (Clavien-Dindo classification).	90 days
Other	Anastomotic leakage	To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.	90 days
Other	Intraoperative outcomes: duration of surgery	To compare the duration of surgery measured in minutes between the two arms	1 day
Other	Intraoperative outcomes: surgical bleeding	To compare the surgical bleeding measured in ml between the two arms	1 day
Other	Intraoperative outcomes: surgical conversion	To compare the incidence of surgical conversion to laparotomy between the two arms	1 day
Other	Genitourinary dysfunction assessed by ICIQ-SF questionnaire	To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire	1 year
Other	Defecatory dysfunction assessed by FSFI and erectile dysfunction questionnaires	To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires	1 year
Primary	Total number of lymph nodes and lymph node ratio.	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.	30 days
Secondary	Local recurrence	To compare the tumor local recurrence rate between the two arms.	5 years
Secondary	Survival	To compare the survival rate (deaths from cancer) between the two arms	5 years