Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-27 @ 9:45 AM
Study NCT ID:
NCT06221995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of resting energy expenditure (kcal/day)', 'timeFrame': 'Before surgery, 1 week postoperatively, 3 months postoperatively', 'description': 'To evaluate total energy needs of patients who undergo proctocolectomy with ileoanal j-pouch'}], 'secondaryOutcomes': [{'measure': 'IBDQ', 'timeFrame': 'Before surgery and 1 week after Surgery', 'description': 'Inflammatory Bowel Disease Questionnaires (IBDQ), a widely used questionnaire for HRQoL assessment in patients with inflammatory bowel diseases (IBDs)'}, {'measure': 'Resting energy expenditure change (kcal/day)', 'timeFrame': '1 week postoperatively and 3 months postoperatively', 'description': 'Changes in daily energy expenditure after surgery compared to pre surgery assesment.'}, {'measure': 'Bristol stool form scale, min: type 1 (hard solid stools, better outcome) - max: type 7 (liquid stools, worst outcome)', 'timeFrame': 'Before surgery, 1 week postoperatively, 6 months after surgery', 'description': 'Longitudinal changes in Bristol stool form scale score before and after surgery.'}, {'measure': 'Post operative weight loss', 'timeFrame': '1 week postoperatively, 3 months postoperatively', 'description': 'Post operative weight loss will be assessed by measuring the post weight on the date of surgery and adjusting for the baseline weight in kg.'}, {'measure': 'Post operative Energy intake.', 'timeFrame': '1 week postoperatively, 3 months postoperatively', 'description': 'Total energy intake measured in calories after surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'energy requirements', 'ileoanal anastomosis', 'j-pouch'], 'conditions': ['Ulcerative Colitis', 'Surgery']}, 'descriptionModule': {'briefSummary': 'A prospective observational study to assess the energy needs of Ulcerative Colitis patients undergoing total proctocolectomy with ileoanal j-pouch anastomosis.', 'detailedDescription': 'Total proctocolectomy with creation of ileoanal j-pouch anastomosis is the gold-standard surgical procedure for familial polyposis, for ulcerative colitis unresponsive to medication and for colitis associated with dysplasia requiring total colectomy.\n\nPatients postoperatively face difficulties in maintaining their physical condition and quality of life due to potential complications such as surgical, mechanical, inflammatory and functional disorders increasing the rates of malnutrition. Postoperative changes as regards anthropometric characteristics and nutritional status have not been fully elucidated.\n\nTherefore, the need arises to calculate the energy needs of patients with ileoanal j-pouch anastomosis, given the lack of corresponding data and the possible differentiation of energy needs from a similar group of patients undergoing colorectal surgery.\n\nOf particular interest is the body composition of ileoanal anastomosis patients, which has been studied very little ), and the extent to which their energy needs are met, given dietary restrictions both preoperatively and postoperatively.\n\nIt is therefore necessary to determine the energy needs, as well as the degree of their coverage by the diet, of UC patients undergoing proctocolectomy with creation of ileoanal j-pouch anastomosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis. As control group, it is planned to enroll patients about to undergo subtotal colectomy, matched with the patient group in terms of gender, age and body mass index.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ulcerative colitis and planned proctocolectomy with ileoanal j-pouch anastomosis surgery or patients who are to undergo subtotal colectomy.\n* Age over 18 years.\n* Written informed consent to take part in the study.\n* Speaking ability in Greek or English.\n* Able to get tested fasted;\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Existence of pregnancy.\n* Inability to breathe inside the indirect calorimetry mask for the time required for the measurement.\n* Use of medications that may affect body metabolism will be evaluated individually (e.g. cortico-steroids etc.)'}, 'identificationModule': {'nctId': 'NCT06221995', 'briefTitle': 'Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Evangelismos Hospital'}, 'officialTitle': 'Energy Requirements in Patients With Ulcerative Colitis Undergoing Total Rectocolectomy and Ileoanal Anastomosis J-pouch', 'orgStudyIdInfo': {'id': 'PouchEH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ulcerative Colitis patients undergoing proctocolectomy', 'description': 'Measurement of resting energy expenditure among patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis', 'interventionNames': ['Diagnostic Test: Indirect Calorimetry']}], 'interventions': [{'name': 'Indirect Calorimetry', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Resting energy expenditure measurement'], 'description': 'Resting energy expenditure measurement', 'armGroupLabels': ['Ulcerative Colitis patients undergoing proctocolectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10676', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Evangelismos General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Dimitrios Karagiannis, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Evangelismos General Hospital of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelismos Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Clinical Nutrition, Evaggelismos General Hospital, Athens', 'investigatorFullName': 'Dimitrios Karayiannis', 'investigatorAffiliation': 'Evangelismos Hospital'}}}}