Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-01-12 @ 11:53 PM
Study NCT ID:
NCT03083951
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2017-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012811', 'term': 'Sigmoid Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012810', 'term': 'Sigmoid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patient does not know the group to which it has been assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2017-03-02', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '90 days', 'description': 'Postoperative complications within 90 days after surgery (Clavien-Dindo classification).'}, {'measure': 'Anastomotic leakage', 'timeFrame': '90 days', 'description': 'To compare the incidence of anastomotic leakage according to the classification of the International Group for Rectal Cancer Study.'}, {'measure': 'Intraoperative outcomes: duration of surgery', 'timeFrame': '1 day', 'description': 'To compare the duration of surgery measured in minutes between the two arms'}, {'measure': 'Intraoperative outcomes: surgical bleeding', 'timeFrame': '1 day', 'description': 'To compare the surgical bleeding measured in ml between the two arms'}, {'measure': 'Intraoperative outcomes: surgical conversion', 'timeFrame': '1 day', 'description': 'To compare the incidence of surgical conversion to laparotomy between the two arms'}, {'measure': 'Genitourinary dysfunction assessed by ICIQ-SF questionnaire', 'timeFrame': '1 year', 'description': 'To compare the Genitourinary dysfunction between the two arm measured by ICIQ-SF questionnaire'}, {'measure': 'Defecatory dysfunction assessed by FSFI and erectile dysfunction questionnaires', 'timeFrame': '1 year', 'description': 'To compare the defecatory dysfunction between the two arms measured by FSFI and erectile dysfunction questionnaires'}], 'primaryOutcomes': [{'measure': 'Total number of lymph nodes and lymph node ratio.', 'timeFrame': '30 days', '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.'}], 'secondaryOutcomes': [{'measure': 'Local recurrence', 'timeFrame': '5 years', 'description': 'To compare the tumor local recurrence rate between the two arms.'}, {'measure': 'Survival', 'timeFrame': '5 years', 'description': 'To compare the survival rate (deaths from cancer) between the two arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complete mesocolon excision', 'Sigmoid cancer', 'Colorectal cancer'], 'conditions': ['Colorectal Cancer', 'Sigmoid Cancer']}, 'referencesModule': {'references': [{'pmid': '37526748', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34417367', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing programmed surgery for laparoscopic sigmoid colon cancer.\n* Age ≥ 18 years and \\<80 years.\n* Histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy.\n* Any T, any N, M0.\n* Intention of resection R0.\n* Informed consent signed by the patient and the investigator.\n\nExclusion Criteria:\n\n* Colorectal tumor with histology other than adenocarcinoma or adenoma.\n* Colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon.\n* Metastatic disease (M1).\n* History of colorectal cancer surgery, different from a local excision.\n* Inflammatory bowel disease with anatomopathological confirmation.\n* Patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent.\n* Inability to read or understand any of the languages of the informed consent (Catalan, Spanish).\n* Another synchronous malignant disease.\n* Emergency surgery.'}, 'identificationModule': {'nctId': 'NCT03083951', 'acronym': 'CMELL', 'briefTitle': 'Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}, 'officialTitle': 'Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)', 'orgStudyIdInfo': {'id': '13117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complete Mesocolon Excision', '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.', 'interventionNames': ['Procedure: Complete mesocolon excision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Locoregional Lymphadenectomy', '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.', 'interventionNames': ['Procedure: Conventional locoregional lymphadenectomy']}], 'interventions': [{'name': 'Complete mesocolon excision', 'type': 'PROCEDURE', '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)', 'armGroupLabels': ['Complete Mesocolon Excision']}, {'name': 'Conventional locoregional lymphadenectomy', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Conventional Locoregional Lymphadenectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'University Hospital Dr. Josep Trueta of Girona', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pere Planellas Giné', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Pere Planellas Giné', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}}}}