Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-06 @ 7:20 AM
Study NCT ID:
NCT07007494
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Outcomes and Nutritional Scores in Bariatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Postoperative Complications Within 72 Hours', 'timeFrame': 'Up to 72 hours after surgery', 'description': 'Complications such as fever, surgical site infection, nausea/vomiting, hypotension, or need for reintervention will be recorded during the first 72 hours after laparoscopic sleeve gastrectomy. The association between preoperative nutritional and inflammatory scores (PNI, HALP, NLR, CRP) and complication occurrence will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications', 'Preoperative Nutritional Markers']}, 'referencesModule': {'references': [{'pmid': '38110235', 'type': 'RESULT', 'citation': 'Courcoulas AP, Daigle CR, Arterburn DE. Long term outcomes of metabolic/bariatric surgery in adults. BMJ. 2023 Dec 18;383:e071027. doi: 10.1136/bmj-2022-071027.'}, {'pmid': '37103068', 'type': 'RESULT', 'citation': 'Ishiguro T, Aoyama T, Ju M, Kazama K, Fukuda M, Kanai H, Sawazaki S, Tamagawa H, Tamagawa A, Cho H, Hara K, Numata M, Hashimoto I, Maezawa Y, Segami K, Oshima T, Saito A, Yukawa N, Rino Y. Prognostic Nutritional Index as a Predictor of Prognosis in Postoperative Patients With Gastric Cancer. In Vivo. 2023 May-Jun;37(3):1290-1296. doi: 10.21873/invivo.13207.'}, {'pmid': '36386497', 'type': 'RESULT', 'citation': 'Xu F, Meng C, Yang Z, Li H, Gao J, Sun L, Zhang X, Wei Q, Wu G, Yao H, Zhang Z. Prognostic nutrition index predicts short-term surgical complications in patients with rectal cancer after laparoscopic surgery. Front Surg. 2022 Oct 25;9:1000108. doi: 10.3389/fsurg.2022.1000108. eCollection 2022.'}, {'pmid': '27149460', 'type': 'RESULT', 'citation': 'Lee JY, Kim HI, Kim YN, Hong JH, Alshomimi S, An JY, Cheong JH, Hyung WJ, Noh SH, Kim CB. Clinical Significance of the Prognostic Nutritional Index for Predicting Short- and Long-Term Surgical Outcomes After Gastrectomy: A Retrospective Analysis of 7781 Gastric Cancer Patients. Medicine (Baltimore). 2016 May;95(18):e3539. doi: 10.1097/MD.0000000000003539.'}, {'pmid': '37878772', 'type': 'RESULT', 'citation': 'Demirpolat MT, Sisik A. Effectiveness of the Modified Hemoglobin, Albumin, Lymphocyte, and Platelet Score in Predicting Weight Loss After Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2024 Jan;34(1):61-66. doi: 10.1089/lap.2023.0333. Epub 2023 Oct 25.'}, {'pmid': '39775392', 'type': 'RESULT', 'citation': 'Radkhah H, Zooravar D, Shateri-Amiri B, Saffar H, Najjari K, Hazaveh MM. Predictive Value of Complete Blood Count (CBC)-Derived Indices-C-Reactive-Protein-Albumin-Lymphocyte index (CALLY), Glucose-to-Lymphocyte Ratio (GLR), Prognostic Nutritional Index (PNI), Hemoglobin, Albumin, Lymphocyte, Platelet (HALP), and Controlling Nutritional Status (COUNT)-on Body Composition Changes After Bariatric Surgery. Obes Surg. 2025 Feb;35(2):544-555. doi: 10.1007/s11695-024-07643-1. Epub 2025 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate whether preoperative immune-nutritional markers-specifically the Prognostic Nutritional Index (PNI), HALP score, Neutrophil-to-Lymphocyte Ratio (NLR), and C-Reactive Protein (CRP)-can predict early postoperative clinical outcomes such as time to oral intake, mobilization, complications, and length of hospital stay in patients undergoing elective laparoscopic sleeve gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18-65 years with morbid obesity (BMI ≥ 35 kg/m²) who are scheduled to undergo elective laparoscopic sleeve gastrectomy at a tertiary care center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Body mass index (BMI) ≥ 35 kg/m²\n* Scheduled for elective laparoscopic sleeve gastrectomy\n* Availability of complete preoperative laboratory test results\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe hepatic or renal dysfunction\n* Presence of active infection\n* History of immunosuppressive therapy or hematologic malignancy\n* Need for intensive care unit (ICU) admission within the first 72 hours postoperatively\n* Preoperative administration of albumin or blood products'}, 'identificationModule': {'nctId': 'NCT07007494', 'briefTitle': 'Early Outcomes and Nutritional Scores in Bariatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'The Relationship Between Preoperative Nutritional and Inflammatory Markers and Early Postoperative Clinical Outcomes in Patients Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': 'PNI HALP OBESITY'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nutritional and Inflammatory Marker Evaluation', 'type': 'OTHER', 'description': 'This is a prospective observational cohort study evaluating whether preoperative immune-nutritional markers-including Prognostic Nutritional Index (PNI), HALP score, Neutrophil-to-Lymphocyte Ratio (NLR), and C-Reactive Protein (CRP)-can predict early postoperative clinical outcomes (complication development, time to oral intake, mobilization, and length of hospital stay) in patients undergoing elective laparoscopic sleeve gastrectomy. No intervention or treatment is administered as part of this study. All data are collected from routine preoperative laboratory tests and standard postoperative clinical follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'state': 'Merkez Mahallesi', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ilke dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com'}, {'name': 'ilke dolgun', 'role': 'CONTACT'}], 'facility': 'Istinye Üniversity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ilke dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}, {'name': 'ilke dolgun', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof', 'investigatorFullName': 'İlke Dolgun', 'investigatorAffiliation': 'Istinye University'}}}}