Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06445920
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2024-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2024-06-02', 'studyFirstSubmitQcDate': '2024-06-02', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically important postoperative nausea and vomiting (CI-PONV)', 'timeFrame': 'The first 24 hours after surgery', 'description': 'The occurrence of PONV with the simplified PONV impact scale score of 5 or more. PONV is defined as PONV as the experience of nausea, retching, or vomiting during the first 24 hours following surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '32467512', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.'}, {'pmid': '12358962', 'type': 'BACKGROUND', 'citation': 'Eberhart LH, Mauch M, Morin AM, Wulf H, Geldner G. Impact of a multimodal anti-emetic prophylaxis on patient satisfaction in high-risk patients for postoperative nausea and vomiting. Anaesthesia. 2002 Oct;57(10):1022-7. doi: 10.1046/j.1365-2044.2002.02822.x.'}, {'pmid': '10740539', 'type': 'BACKGROUND', 'citation': 'Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.'}, {'pmid': '27746521', 'type': 'BACKGROUND', 'citation': 'Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.'}, {'pmid': '16846542', 'type': 'BACKGROUND', 'citation': 'Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.'}, {'pmid': '22223185', 'type': 'BACKGROUND', 'citation': 'Parra-Sanchez I, Abdallah R, You J, Fu AZ, Grady M, Cummings K 3rd, Apfel C, Sessler DI. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012 Apr;59(4):366-75. doi: 10.1007/s12630-011-9660-x. Epub 2012 Jan 6.'}, {'pmid': '10485781', 'type': 'BACKGROUND', 'citation': 'Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.'}, {'pmid': '37259031', 'type': 'BACKGROUND', 'citation': 'Zhou CM, Wang Y, Xue Q, Yang JJ, Zhu Y. Predicting early postoperative PONV using multiple machine-learning- and deep-learning-algorithms. BMC Med Res Methodol. 2023 May 31;23(1):133. doi: 10.1186/s12874-023-01955-z.'}, {'pmid': '37892882', 'type': 'BACKGROUND', 'citation': 'Kim JH, Cheon BR, Kim MG, Hwang SM, Lim SY, Lee JJ, Kwon YS. Postoperative Nausea and Vomiting Prediction: Machine Learning Insights from a Comprehensive Analysis of Perioperative Data. Bioengineering (Basel). 2023 Oct 1;10(10):1152. doi: 10.3390/bioengineering10101152.'}, {'pmid': '33673875', 'type': 'BACKGROUND', 'citation': "Edgman-Levitan S, Schoenbaum SC. Patient-centered care: achieving higher quality by designing care through the patient's eyes. Isr J Health Policy Res. 2021 Mar 5;10(1):21. doi: 10.1186/s13584-021-00459-9."}, {'pmid': '22290456', 'type': 'BACKGROUND', 'citation': 'Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.'}, {'pmid': '38466940', 'type': 'BACKGROUND', 'citation': 'Hubbard RA, Su YR, Bowles EJA, Ichikawa L, Kerlikowske K, Lowry KP, Miglioretti DL, Tosteson ANA, Wernli KJ, Lee JM. Predicting five-year interval second breast cancer risk in women with prior breast cancer. J Natl Cancer Inst. 2024 Jun 7;116(6):929-937. doi: 10.1093/jnci/djae063.'}, {'pmid': '38694132', 'type': 'BACKGROUND', 'citation': 'Liu J, Yu Y, Qi W, Ma X, Han Y. Innovation and entrepreneurship of Chinese returning migrant workers in their home region. Heliyon. 2024 Apr 26;10(9):e30296. doi: 10.1016/j.heliyon.2024.e30296. eCollection 2024 May 15.'}, {'pmid': '31956740', 'type': 'BACKGROUND', 'citation': 'Portet S. A primer on model selection using the Akaike Information Criterion. Infect Dis Model. 2020 Jan 7;5:111-128. doi: 10.1016/j.idm.2019.12.010. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative nausea and vomiting (PONV) is a distressing and common complication after surgery. The concept of clinical important PONV (CI-PONV) assesses the impact of PONV on patient-reported outcomes. This research aims to conduct an analysis of the risk factors contributing to CI-PONV utilizing the least absolute shrinkage and selection operator (LASSO) and stepwise regression techniques. All 1154 patients participating in the FDP-PONV trial are included in this study and categorized into two groups: the CI-PONV group and the non-CI-PONV group. CI-PONV is defined as the occurrence of PONV with a simplified PONV impact scale score of 5 or higher within 24 hours after surgery. The LASSO method is employed to identify the most relevant variables from an initial set of 56 related variables and stepwise regression is used to further refine the selection of the ultimate predictors.A logistic regression model was developed based on the selected factors influencing CIPONV. A nomogram was developed as a tool for clinical application.', 'detailedDescription': 'Drawing from prior studies, we conducted a sample size calculation for a predictive model using the website https://mvansmeden.shinyapps.io/BeyondEPV/. By setting the number of candidate predictors to 9, the events fraction to 0.14, and the criterion value for rMPSE to 0.04, we determined that a minimum total sample size of 900 is required, with a minimally expected event per variable of 13.9. All patients were classified into either the CI-PONV group or the non-CI-PONV group. All 56 perioperative clinical features, encompassing baseline characteristics, preoperative conditions, and intraoperative information, were considered as potential predictive factors. In the quest to uncover potential predictive factors associated with CI-PONV, we employed the least absolute shrinkage and selection operator (LASSO) to sift through clinically significant variables. Subsequently, we utilized stepwise regression based on the Akaike Information Criterion (AIC) to further refine the selection of the ultimate predictors. Finally, a logistic regression model was developed based on the selected factors influencing CIPONV. The discrimination of the model was assessed by the ROCAUC and the goodness of fit of the model was evaluated using the Hosmer-Lemeshow test and calibration plots. A nomogram based on the logistic regression model output was developed as a tool for clinical application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All 1154 patients in the FDP-PONV trial will be enrolled in this study. The FDP-PONV trial was a randomized, controlled, double-blind trial that aimed to evaluate the effectiveness and safety of fosaprepitant in managing PONV in patients undergoing laparoscopic gastrointestinal surgery. The FDP-PONV trial was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (2021ZSLYEC-78), and registered at Clinicaltrials.gov (NCT04853147).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\na) age between 18 and 75 years, b) having 3 or 4 Apfel risk factors, and c) scheduled to undergo laparoscopic gastrointestinal surgical procedures under general anesthesia.\n\nExclusion Criteria:\n\na) American Society of Anesthesiologists (ASA) physical status greater than 3, b) severe hepatic dysfunction, c) contraindications to fosaprepitant, 5-HT3 receptor antagonist, or dexamethasone, d) preoperative use of medications known to have antiemetic properties, e) presence of mental disorders or inability to communicate, and f) pregnant or nursing women.'}, 'identificationModule': {'nctId': 'NCT06445920', 'briefTitle': 'Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery Based on LASSO and Stepwise Regression', 'orgStudyIdInfo': {'id': '2024ZSLYEC-201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIPONV', 'description': 'The occurrence of PONV with the simplified PONV impact scale score of 5 or more.', 'interventionNames': ['Other: No Intervention']}, {'label': 'Non-CIPONV', 'description': 'There was no occurrence of PONV, or if PONV occurred, the simplified PONV impact scale score was less than 5.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['CIPONV', 'Non-CIPONV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Anesthesia, The Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zhinan Zheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sixth Affiliated Hospital, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor', 'investigatorFullName': 'Zhi-Nan Zheng', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}