Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
NCT ID: NCT03083951
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2017-09-01
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
79 Years
ALL
No
Sponsors
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Pere Planellas Giné
OTHER
Responsible Party
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Pere Planellas Giné
Principal investigator
Locations
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University Hospital Dr. Josep Trueta of Girona
Girona, , Spain
Countries
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References
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Planellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Impact on defecatory, urinary and sexual function after high-tie sigmoidectomy: a post-hoc analysis of a multicenter randomized controlled trial comparing extended versus standard complete mesocolon excision. Langenbecks Arch Surg. 2023 Aug 1;408(1):293. doi: 10.1007/s00423-023-03026-9.
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.
Other Identifiers
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13117
Identifier Type: -
Identifier Source: org_study_id
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