Clinical trial NCT03083951: Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Official title: Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Sigmoid Cancer
Keywords: Complete mesocolon excision
Sigmoid cancer
Colorectal cancer
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total number of lymph nodes and lymph node ratio.
timeFrame: 30 days
Secondary outcomes:
measure: Local recurrence
timeFrame: 5 years
measure: Survival
timeFrame: 5 years
Other outcomes:
measure: Postoperative complications
timeFrame: 90 days
measure: Anastomotic leakage
timeFrame: 90 days
measure: Intraoperative outcomes: duration of surgery
timeFrame: 1 day
measure: Intraoperative outcomes: surgical bleeding
timeFrame: 1 day
measure: Intraoperative outcomes: surgical conversion
timeFrame: 1 day
measure: Genitourinary dysfunction assessed by ICIQ-SF questionnaire
timeFrame: 1 year
measure: Defecatory dysfunction assessed by FSFI and erectile dysfunction questionnaires
timeFrame: 1 year
Locations:
city: Girona
country: Spain
facility: University Hospital Dr. Josep Trueta of Girona
Study officials:
References:
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.