Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-04 @ 4:21 PM
Study NCT ID:
NCT05323604
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sarcopenia Using an Easy Psoas Area Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003082', 'term': 'Colectomy'}], 'ancestors': [{'id': 'D000099090', 'term': 'Surgical Procedures, Colorectal'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the average postoperative length of stay in sacopenic and non-sarcopenic patients', 'timeFrame': 'Until discharge from hospital, an average of 30 days', 'description': 'Comparison of the number of post-operative hospital days between the two groups'}], 'secondaryOutcomes': [{'measure': 'Comparison between complication rate in sarcopenic and non sarcopenic patients', 'timeFrame': 'At the end of the 30 post-operative days', 'description': 'Measurement of the complication rate according to the Clavien Dindo score (relevant score if greater than or equal to 2, considered severe complication if greater than or equal to 3) between the two groups'}, {'measure': 'Assessment of re-hospitalization rate between sarcopenic and non sarcopenic patients', 'timeFrame': 'At the end of the 30 post-operative days', 'description': 'Evaluation of the number of hospitalizations of more than 24 hours at 30 days after the operation between the two groups'}, {'measure': 'Comparison of the transfer rate to rehabilitation or nursing home center between sarcopenic and non sarcopenic patients', 'timeFrame': 'At the end of the 30 post-operative days', 'description': 'Evaluation of the number of transfer to rehabilitation or nursing home center at 30 days after the operation between the two groups'}, {'measure': 'Comparison of the length of stay in the rehabilitation center for sarcopenic and non sarcopenic transferred patients', 'timeFrame': 'At the end of the 30 post-operative days', 'description': 'Comparison of the number of hospital days for transferred patients between the two groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'colorectal neoplasm', 'colorectal surgery', 'psoas muscles'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the post-operative course in patients suffering from sarcopenia who had colorectal surgery for cancer. Our primary outcome is the comparaison of the length of hospital stay in sarcopenic and non sarcopenic patients.', 'detailedDescription': 'Sarcopenia is the loss of muscle mass that occurs usually with aging, but it may have multiple contributing factors, especially related to chronic diseases such as colorectal cancer.\n\nWhen present, sarcopenia is predictive of poor post-operative course. The identification of sarcopenia needs either the identification of low muscle strength, low muscle quantity/quality, or finally a low physical performance.\n\nMultiple clinical, biological or radiological tools were proposed. Our purpose is to compare the post-operative outcome of sarcopenic and non sarcopenic patients using a simple, available, reproducible and rapid radiological method, which will help the healthcare professionals to rapidly identify high risk patients for possible complicated and long post-operative course allowing them to take appropriate perioperative measures to reduce the risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from sarcopenia who had colorectal surgery for cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient operated on for colectomy or proctectomy with restoration of continuity for colorectal cancer between 1 January 2020 and 31 December 2021\n* Patient who had a CT scan in the 2 months prior surgery\n* Patient aged 18 years or older\n\nExclusion Criteria:\n\n* Patients with inflammatory bowel disease (Crohn disease, haemorrhagic rectocolitis)\n* Patients with neuromuscular pathology affecting their mobility\n* Patients who were diagnosed positif to SARS COV 2 before or during hospitalisation\n* Patients who refuse the collection of their data'}, 'identificationModule': {'nctId': 'NCT05323604', 'acronym': 'ISEPAM', 'briefTitle': 'Impact of Sarcopenia Using an Easy Psoas Area Measurement', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'Impact of Sarcopenia on Post-operative Course for Cancer Patients Operated of Colorectal Surgery Using a Simple Measurement Method of the Psoas Muscle Surface Area', 'orgStudyIdInfo': {'id': 'CHRD3021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colectomy with anastomosis of any type', 'description': 'Patient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy', 'interventionNames': ['Other: Colectomy with anastomosis of any type']}], 'interventions': [{'name': 'Colectomy with anastomosis of any type', 'type': 'OTHER', 'description': 'Patient with colonic resection followed by ileocolic, or colo colic, or colorectal, or coloanal anastomosis for cancer by laparoscopy or laparotomy', 'armGroupLabels': ['Colectomy with anastomosis of any type']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'Centre Hospitalier René Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}], 'overallOfficials': [{'name': 'Hicham El Masri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital René Dubos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}