Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-26 @ 7:21 PM
Study NCT ID:
NCT03107650
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality)', 'timeFrame': '30 days', 'description': 'Evaluation of the quality of mesorectum as optimal or suboptimal (international consensus defines three grades of resection:\n\nGroup 1: including mesorectal resection, good quality Group 2: intramesorectal resection: moderate quality Group 3: resection in the muscularis propria, poor quality).\n\nInvestigators will group patients into two groups: optimal mesorectum (group 1) and suboptimal mesorectum (group 2-3).'}, {'measure': 'Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)', 'timeFrame': '30 days', 'description': 'Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '2 years', 'description': 'Rate of tumor recurrence'}, {'measure': 'Survival', 'timeFrame': '2 years', 'description': 'Rate of survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'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.'}, {'pmid': '33244719', 'type': 'DERIVED', 'citation': 'Planellas P, Salvador H, Cornejo L, Buxo M, Farres R, Molina X, Maroto A, Ortega N, Rodriguez-Hermosa JI, Codina-Cazador A. Risk factors for suboptimal laparoscopic surgery in rectal cancer patients. Langenbecks Arch Surg. 2021 Mar;406(2):309-318. doi: 10.1007/s00423-020-02029-0. Epub 2020 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'Elaboration of a preoperative prediction model of the quality of the mesorectum and the involvement of the circumferential margin in patients with mid-low rectal cancer who undergo laparoscopic anterior rectal resection.\n\nIn a second phase the investigators will study the utility of the prediction model in classifying patients with high risk of suboptimal quality of mesorectum and/or positive circumferential margin. Patients with high preoperative risk will undergo a transanal total mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal excision. The investigators finally will compare pathological outcomes ( quality of mesorectum and circumferential margin), survival and recurrence between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected of mid-low rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients directed to laparoscopic anterior rectal resection through a transabdominal or a transanal approach.\n* Age ≥ 18 years\n* Histology of adenocarcinoma or adenoma\n* With or without neoadjuvant chemoradiotherapy\n* TNM classification: T2 or T3, any N stage or M stage\n* Intention of resection R0\n\nExclusion Criteria:\n\n* TNM classification: T1 or T4.\n* Complicated rectal cancer or emergency surgery.\n* Previous major colorectal surgery'}, 'identificationModule': {'nctId': 'NCT03107650', 'acronym': 'PREMARE', 'briefTitle': 'Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}, 'officialTitle': 'Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer', 'orgStudyIdInfo': {'id': '0485762'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk patients', 'description': 'Patients with high risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed', 'interventionNames': ['Procedure: Transanal total mesorectal excision of rectal cancer']}, {'label': 'Low risk patients', 'description': 'Patients with low risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed'}], 'interventions': [{'name': 'Transanal total mesorectal excision of rectal cancer', 'type': 'PROCEDURE', 'description': 'To perform a total mesorectal excision through a transanal approach', 'armGroupLabels': ['High risk patients']}]}, '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': 'MD PhD', 'investigatorFullName': 'Pere Planellas Giné', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}}}}