Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 7:58 AM
Study NCT ID:
NCT05110235
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEG Application Experiences to Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin (gr/dl)', 'timeFrame': '30 days', 'description': '30 th day hemoglobin levels after PEG application'}, {'measure': 'Albumin (gr/dl)', 'timeFrame': '30 days', 'description': '30 th day albumin levels after PEG application'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geriatrics', 'Nutrition', 'PEG', 'Gastrostomy'], 'conditions': ['Nutrient Deficiency', 'Gastrostomy']}, 'descriptionModule': {'briefSummary': 'Percutaneous endoscopic gastrostomy (PEG) is currently the chosen minimally invasive, endoscopic procedure for medium- and long-term enteral feeding in cases who need palliative care. The presented study evaluated geriatric (\\> 65-year-old) PEG-applied patients at our institution.', 'detailedDescription': "Palliative care is a treatment method that focuses on the patient and patient's family, aims to minimize the complaints caused by chronic diseases that cannot be treated, and increases life quality. The National Institute for Health and Care Excellence defines palliative care as; the active, holistic care of patients with an advanced progressive illness. Management of pain and other symptoms and providing psychological, social, and spiritual support is paramount. Anorexia, weight loss, and sarcopenia are highly visible and distressing reminders of the life-limiting disease's influence on patients who require palliative care. Given this multifaceted and significant role, it is not unexpected that nutritional treatment method choices can be challenging.\n\nPercutaneous endoscopic gastrostomy (PEG) is a minimally-invasive endoscopic procedure that creates a passage from the patient's stomach to the abdominal wall via a feeding tube and provides a means of feeding if oral intake is not adequate. This safe and effective minimally-invasive option has been utilized in medical practice for over 40 years. PEG has advantages such as being minimally invasive, causing a low rate of complications and morbidity, and providing a long-lasting and safe feeding route. It is currently the chosen procedure for medium- and long-term enteral feeding in cases who need palliative care.\n\nThe application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, this minimally invasive method can be applied more safely, even in challenging cases. This study discuss the indications of PEG in the field of palliative care of geriatric patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We retrospectively assessed the medical datum of PEG applied \\>65-year-old patients at our institution between December 2017 and March 2021. And, we excluded the patients who were not treated in our palliative care center. Table 1. shows the contraindications for PEG placement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: PEG applied \\>65-year-old patients at our institution between December 2017 and March 2021 -\n\nExclusion Criteria: We excluded the patients who were not treated in our palliative care center\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05110235', 'briefTitle': 'PEG Application Experiences to Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': 'PERCUTANEOUS ENDOSCOPIC GASTROSTOMY APPLICATION EXPERIENCES TO GERIATRIC PATIENTS IN PALLIATIVE CARE UNIT', 'orgStudyIdInfo': {'id': '56665618-204.01.08'}}, 'contactsLocationsModule': {'locations': [{'zip': '34734', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Okan University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Assistant Professor, Principal investigator', 'investigatorFullName': 'Murat Ferhat Ferhatoglu', 'investigatorAffiliation': 'Okan University'}}}}