Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL) (CMELL)
September 28, 2023 updated by: Pere Planellas Giné
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Girona, Spain, 17007
- University Hospital Dr. Josep Trueta of Girona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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)
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 (defined as ratio of lymph nodes with tumor metastasis to the total lymph nodes resected) between the two arms.
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30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Local recurrence
Time Frame: 5 years
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To compare the tumor local recurrence rate between the two arms.
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5 years
|
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Survival
Time Frame: 5 years
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To compare the survival rate (deaths from cancer) between the two arms
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5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications
Time Frame: 90 days
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Postoperative complications within 90 days after surgery (Clavien-Dindo classification).
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90 days
|
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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.
|
90 days
|
|
Intraoperative outcomes: duration of surgery
Time Frame: 1 day
|
To compare the duration of surgery measured in minutes between the two arms
|
1 day
|
|
Intraoperative outcomes: surgical bleeding
Time Frame: 1 day
|
To compare the surgical bleeding measured in ml between the two arms
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1 day
|
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Intraoperative outcomes: surgical conversion
Time Frame: 1 day
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To compare the incidence of surgical conversion to laparotomy between the two arms
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1 day
|
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Genitourinary dysfunction assessed by ICIQ-SF questionnaire
Time Frame: 1 year
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To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire
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1 year
|
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Defecatory dysfunction assessed by FSFI and erectile dysfunction questionnaires
Time Frame: 1 year
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To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 13, 2017
First Posted (Actual)
March 20, 2017
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 28, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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