Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT06405412
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiorespiratory advers events', 'timeFrame': 'up to 12 weeks', 'description': 'hypercapnia (above 45mmHg)'}, {'measure': 'postoperative renal complications', 'timeFrame': 'up to 12 weeks', 'description': 'serum creatinine 0.3 mg/dL rise'}], 'secondaryOutcomes': [{'measure': 'Malnutrition condition', 'timeFrame': 'up to 12 weeks', 'description': 'serum albumin (3.4 to 5.4 g/dL)'}, {'measure': 'escart score', 'timeFrame': 'up to 12 weeks', 'description': 'weight loss ( \\<5kg to10kg\\>)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peroral Endoscopic Myotomy', 'anesthesia', 'Esophageal Achalasia'], 'conditions': ['Esophageal Achalasia']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.', 'detailedDescription': 'The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.\n\nThe secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this retrospective cohort study, 50 patients diagnosed with achalasia who applied to the Gastroenterology department of Ümraniye Training and Research Hospital between October 2021 and February 2024 and were indicated for POEM treatment will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Criteria for inclusion in the study:\n* Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians\n* ASA 1-3\n* Between the ages of 18-80\n\nExclusion Criteria:\n\n* Criteria for exclusion from the study:\n* Those with a known history of active lung infection, advanced COPD, or respiratory failure\n* Patients with EF below 40%, severe ischemic heart failure, presence of valve disease\n* Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand)\n* severe kidney dysfunction\n* In the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both\n* Pre-existing increased intracranial pressure\n* Having a BMI \\>30\n* Severe uncorrected hypovolemiaHistory of radiotherapy to the esophagus\n* History of mucosal resection or ablation in the area where POEM will be applied\n* Presence of cirrhosis and portal hypertension.'}, 'identificationModule': {'nctId': 'NCT06405412', 'briefTitle': 'Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)', 'orgStudyIdInfo': {'id': 'UERH-AR-ZT-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild malnutrition', 'description': 'Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition)', 'interventionNames': ['Other: MUST malnutrition score']}, {'label': 'Moderate malnutrition', 'description': 'Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition)', 'interventionNames': ['Other: MUST malnutrition score']}, {'label': 'Severe malnutrition', 'description': 'Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition)', 'interventionNames': ['Other: MUST malnutrition score']}], 'interventions': [{'name': 'MUST malnutrition score', 'type': 'OTHER', 'description': 'MUST malnutrition score', 'armGroupLabels': ['Mild malnutrition', 'Moderate malnutrition', 'Severe malnutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34764', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zeliha Tuncel', 'role': 'CONTACT', 'email': 'zelihalara@yahoo.com', 'phone': '0216 632 18 18'}, {'name': 'Harika Duygu Ozer', 'role': 'CONTACT', 'email': 'harikaduyguozer@gmail.com', 'phone': '0216 632 18 18'}], 'facility': 'Umraniye Education and Research hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'zeliha tuncel', 'role': 'CONTACT', 'email': 'zelihalara@yahoo.com', 'phone': '05053577483'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Anesthesiologist', 'investigatorFullName': 'Zeliha Alicikus', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}