Back to resultsComplete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL) (CMELL)
Primary Purpose
Colorectal Cancer, Sigmoid Cancer
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Complete mesocolon excision
Conventional locoregional lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Complete mesocolon excision, Sigmoid cancer, Colorectal cancer
Eligibility 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 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.
Sites / Locations
- University Hospital Dr. Josep Trueta of Girona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Complete Mesocolon Excision
Conventional Locoregional Lymphadenectomy
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Local recurrence
To compare the tumor local recurrence rate between the two arms.
Survival
To compare the survival rate (deaths from cancer) between the two arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03083951
Brief Title
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Acronym
CMELL
Official Title
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pere Planellas Giné
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Sigmoid Cancer
Keywords
Complete mesocolon excision, Sigmoid cancer, Colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The patient does not know the group to which it has been assigned.
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Complete Mesocolon Excision
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Locoregional Lymphadenectomy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Complete mesocolon excision
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Conventional locoregional lymphadenectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total number of lymph nodes and lymph node ratio.
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Local recurrence
Description
To compare the tumor local recurrence rate between the two arms.
Time Frame
5 years
Title
Survival
Description
To compare the survival rate (deaths from cancer) between the two arms
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Postoperative complications
Description
Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
Time Frame
90 days
Title
Anastomotic leakage
Description
To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.
Time Frame
90 days
Title
Intraoperative outcomes: duration of surgery
Description
To compare the duration of surgery measured in minutes between the two arms
Time Frame
1 day
Title
Intraoperative outcomes: surgical bleeding
Description
To compare the surgical bleeding measured in ml between the two arms
Time Frame
1 day
Title
Intraoperative outcomes: surgical conversion
Description
To compare the incidence of surgical conversion to laparotomy between the two arms
Time Frame
1 day
Title
Genitourinary dysfunction assessed by ICIQ-SF questionnaire
Description
To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire
Time Frame
1 year
Title
Defecatory dysfunction assessed by FSFI and erectile dysfunction questionnaires
Description
To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Facility Information:
Facility Name
University Hospital Dr. Josep Trueta of Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34417367
Citation
Planellas 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.
Results Reference
derived
Learn more about this trial
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
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