Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-02 @ 8:06 AM
Study NCT ID:
NCT06573632
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative TPN Improves Surgical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-21', 'size': 511502, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-23T02:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'studying the effects of TPN on length of hospital stay', 'timeFrame': 'through study completion, an average of 5years', 'description': 'comparison of perioperative and postoperative TPN in terms of mean length of stay in days'}, {'measure': 'studying the effects of TPN on mortality', 'timeFrame': 'through study completion, an average of 5years', 'description': 'comparison of perioperative and postoperative TPN in terms of number of mortality cases'}, {'measure': 'studying the effects of TPN on complications using grades', 'timeFrame': 'through study completion, an average of 5years', 'description': 'comparison of perioperative and postoperative TPN in terms of Clavien-Dindo classification grades'}, {'measure': 'studying the effect of albumin levels on length of hospital stay', 'timeFrame': 'through study completion, an average of 5years', 'description': 'comparison of low and normal albumin levels in terms of mean length of stay in days'}, {'measure': 'studying the effect of albumin levels on mortality', 'timeFrame': 'through study completion, an average of 5years', 'description': 'comparison of low and normal albumin levels in terms of number of mortality cases'}, {'measure': 'studying the effect of albumin levels on complication using grades', 'timeFrame': 'through study completion, an average of 5years', 'description': 'comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parenteral nutrition', 'TPN', 'major surgery', 'malnutrition in surgery', 'clavien-dindo classification'], 'conditions': ['Parenteral Nutrition', 'Major Surgery', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '20375423', 'type': 'BACKGROUND', 'citation': 'Jensen GL, Mirtallo J, Compher C, Dhaliwal R, Forbes A, Grijalba RF, Hardy G, Kondrup J, Labadarios D, Nyulasi I, Castillo Pineda JC, Waitzberg D; International Consensus Guideline Committee. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):156-9. doi: 10.1177/0148607110361910.'}, {'pmid': '26688128', 'type': 'BACKGROUND', 'citation': 'Thomas MN, Kufeldt J, Kisser U, Hornung HM, Hoffmann J, Andraschko M, Werner J, Rittler P. Effects of malnutrition on complication rates, length of hospital stay, and revenue in elective surgical patients in the G-DRG-system. Nutrition. 2016 Feb;32(2):249-54. doi: 10.1016/j.nut.2015.08.021. Epub 2015 Sep 25.'}, {'pmid': '32384662', 'type': 'BACKGROUND', 'citation': 'Lakananurak N, Gramlich L. The Role of Preoperative Parenteral Nutrition. Nutrients. 2020 May 6;12(5):1320. doi: 10.3390/nu12051320.'}, {'pmid': '27112357', 'type': 'BACKGROUND', 'citation': 'Zhao XF, Wu N, Zhao GQ, Liu JF, Dai YF. Enteral nutrition versus parenteral nutrition after major abdominal surgery in patients with gastrointestinal cancer: a systematic review and meta-analysis. J Investig Med. 2016 Jun;64(5):1061-74. doi: 10.1136/jim-2016-000083. Epub 2016 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. So the investigators aim to find the impact of TPN in malnutritional surgical patients.', 'detailedDescription': 'Any patient who is at risk of malnutrition as well as already malnutritioned were given preoperative TPN for 5 days. After 5 days, elective surgery was done and TPN was continued postoperatively until patient could consume 50% of their daily requirements orally. Patients who underwent emergency surgeries were also enrolled in this study as these patients could receive TPN only postoperatively.\n\nDaily patient charting with Clavien Dindo Classification, length of stay and mortality were mentioned and verified by the operating surgical team.\n\nData was maintained electronically by the surgical team. Data was also entered in MS-EXCEL at the time of patient discharge. Since data was maintained on everyday basis till patient discharge and does not include follow-ups, there are no missing data.\n\nUpon completion of study, all data will be exported to SPSS and analyzed accordingly using means, SDs, Chi-square and Fisher exact test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to the Surgery department at Nepal Medical College teaching hospital and having malnutrition.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. All patients who underwent major gastrointestinal surgery and received perioperative TPN or postoperative TPN\n\nExclusion Criteria:\n\n* Perioperative TPN administration that did not follow the study protocol\n* TPN given for reasons other than malnutrition'}, 'identificationModule': {'nctId': 'NCT06573632', 'briefTitle': 'Perioperative TPN Improves Surgical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Nepal Medical College and Teaching Hospital'}, 'officialTitle': 'Does Perioperative Parenteral Nutrition Affect Outcome in Patients Undergoing Major Abdominal Surgeries', 'orgStudyIdInfo': {'id': '26-079/080'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malnutrition', 'description': 'All malnutrition patients to received TPN for 5 days preoperatively as applicable and continued postoperatively.', 'interventionNames': ['Dietary Supplement: TPN-N7 Baxter']}], 'interventions': [{'name': 'TPN-N7 Baxter', 'type': 'DIETARY_SUPPLEMENT', 'description': 'providing TPN to all malnutrition patients preoperatively as well as postoperatively.', 'armGroupLabels': ['Malnutrition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kathmandu', 'state': 'Bagmati', 'country': 'Nepal', 'facility': 'Nepal Medical College Teaching Hospital', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nepal Medical College and Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr. Nabin Pokharel, Head of Department of Surgical Gastroenterology', 'investigatorFullName': 'Nabin Pokharel', 'investigatorAffiliation': 'Nepal Medical College and Teaching Hospital'}}}}