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

• ClinicalTrials.gov Identifier: NCT03083951
• Recruitment Status: Active, not recruiting
• First Posted: March 20, 2017
• Last Update Posted: September 10, 2019
• Sponsor: Pere Planellas Giné
• Information provided by (Responsible Party): Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Sigmoid Cancer	Procedure: Complete mesocolon excision; Procedure: Conventional locoregional lymphadenectomy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial, single blind (the patient does not know the group to which it has been assigned) of patients undergoing laparoscopic sigmoid colon cancer resection. In all patients a lymphadenectomy with a high ligation of the Lower Mesenteric Artery will be performed. In patients in group 1A, lymphadenectomy will also include the lymphogranular tissue that accompanies the inferior mesenteric vein from its origin (complete mesocolon excision). In patients in group 1B, a conventional lymphadenectomy will be performed only from the origin of the inferior mesenteric artery without including the lymphatic tissue of the origin of the inferior mesenteric vein.
• Masking: Single (Participant)
• Masking Description: The patient does not know the group to which it has been assigned.
• Primary Purpose: Treatment
• Official Title: Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: June 1, 2019
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Complete Mesocolon Excision; 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.	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)
Active Comparator: Conventional Locoregional Lymphadenectomy; 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Total number of lymph nodes and lymph node ratio. [ Time Frame: 30 days ]
   To compare the total number of lymph nodes resected and the lymph node ratio (definded as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.

Secondary Outcome Measures :

1. Local recurrence [ Time Frame: 5 years ]
   To compare the tumor local recurrence rate between the two arms.
2. Survival [ Time Frame: 5 years ]
   To compare the survival rate (deaths from cancer) between the two arms

Other Outcome Measures:

1. Postoperative complications [ Time Frame: 90 days ]
   Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
2. Anastomotic leakage [ Time Frame: 90 days ]
   To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.
3. Intraoperative outcomes: duration of surgery [ Time Frame: 1 day ]
   To compare the duration of surgery measured in minutes between the two arms
4. Intraoperative outcomes: surgical bleeding [ Time Frame: 1 day ]
   To compare the surgical bleeding measured in ml between the two arms
5. Intraoperative outcomes: surgical conversion [ Time Frame: 1 day ]
   To compare the incidence of surgical conversion to laparotomy between the two arms
6. Genitourinary dysfunction assesed by ICIQ-SF questionnaire [ Time Frame: 1 year ]
   To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire
7. Defecatory dysfunction assesed by FSFI and erectile dysfunction questionnaires [ Time Frame: 1 year ]
   To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 pmpedes 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.

Contacts and Locations

Locations

Spain

University Hospital Dr. Josep Trueta of Girona

Girona, Spain, 17007

Sponsors and Collaborators

Pere Planellas Giné

More Information

• Responsible Party: Pere Planellas Giné, Principal investigator, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• ClinicalTrials.gov Identifier: NCT03083951 History of Changes
• Other Study ID Numbers: 13117
• First Posted: March 20, 2017
• Last Update Posted: September 10, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:

Complete mesocolon excision; Sigmoid cancer; Colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Sigmoid Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Colonic Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Sigmoid Diseases