Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-03 @ 8:42 PM
Study NCT ID:
NCT03749668
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calorie and protein intakes', 'timeFrame': 'one month after hospital discharge', 'description': 'Using a dietary survey postoperative intake of calories and protein will be assessed in patients scheduled for colorectal surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery: colorectal', 'enhanced recovery', 'caloric intake', 'protein intake'], 'conditions': ['Colorectal Surgery', 'Calorie Deficiency']}, 'descriptionModule': {'briefSummary': 'This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients', 'detailedDescription': 'For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, some criticize ERP arguing that patients are asked to return home too early, while they have not recovered a satisfactory autonomy. Few studies have investigated the comfort and quality of home life of patients who have had ERP. We recently conducted a retrospective study to evaluate this quality of life. It turns out that patients report little postoperative pain, a sufficient degree of autonomy at home, and a high general satisfaction score (\\> 8.5 on a numerical scale of 0 to 10). However dietary and digestive difficulties were described by about one third of the patients questioned. \\[6\\] Others have also reported a caloric-protein deficit during the immediate postoperative period after colorectal surgery, up to the 7th day in some of their patients \\[7\\].\n\nAim of the study. The aim of this study is to assess caloric-protein intake up to one month after colorectal surgery within ERP.\n\nGeneral description. This observational study will quantify caloric-protein intake in 75 patients undergoing colorectal surgery according to an ERP at CHU Liège. A dietary survey will be performed preoperatively and repeated postoperatively via telephone calls on Day + 3, Day + 7; Day + 15, and Day + 30, after leaving the hospital. The deficits observed will be correlated with the medical and surgical characteristics of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient schedules for colorectal surgery with the ERP at CHU Liège (Belgium). Patients age must be greater than 18 years. There is no maximum limit of age.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient scheduled for colorectal surgery within an ERP at CHU Liège\n\nExclusion Criteria:\n\n* unable to answer the survey (cognitive disorders, bad knowledge of the French language)\n* closure of loop ileostomy'}, 'identificationModule': {'nctId': 'NCT03749668', 'acronym': 'DIETERP', 'briefTitle': 'Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP).', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Dietary Survey During the First Month After Colorectal Surgery Within an Enhanced Recovery Program', 'orgStudyIdInfo': {'id': '2018-270'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non applicable', 'type': 'OTHER', 'description': 'no intervention in this observational study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liège', 'country': 'Belgium', 'facility': 'University Hospital', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Jean-François Brichant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Liege, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Anesthesiology department', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}