Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04663958
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Ariscat Index In The Development of Pulmonary Complication After Major Abdominal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-05', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of the ARISCAT risk scoring index', 'timeFrame': 'postoperative first 7 days', 'description': 'to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing major abdominal cancer surgery'}], 'secondaryOutcomes': [{'measure': 'Correlation between age (years) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between age (years) and PPC'}, {'measure': 'Correlation between gender(male or female) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between gender (male or female) and PPC'}, {'measure': 'Correlation between BMI (kg/m^2) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between BMI (kg/m\\^2) and PPC'}, {'measure': 'Correlation between history of smoking and the amount of cigarette consumption level (packs/year) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between smoking level (packs/year) and PPC'}, {'measure': 'Correlation between ASA physical score (1-4) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between ASA physical score (1-4) and PPC'}, {'measure': 'Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between Preoperative Sp02(\\>96%, 91%-95%, \\<90%) and PPC'}, {'measure': 'Correlation between preoperative hemoglobulin values (gram / deciliter) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between preoperative hemoglobulin values (gram / deciliter) and PPC'}, {'measure': 'Correlation between surgical incision side (lower-upper abdominal) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between surgical incision side (lower-upper abdominal) and PPC'}, {'measure': 'Correlation between laparoscopic or open surgery and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between laparoscopic or open surgery and PPC'}, {'measure': 'Correlation between , emergency or elective surgery and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between , emergency or elective surgery and PPC'}, {'measure': 'Correlation between the duration of operation (<2 hours, 2-3 hours, more than 3 hours) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between the duration of operation (\\<2 hours, 2-3 hours, more than 3 hours) and PPC'}, {'measure': 'Correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC', 'timeFrame': 'postoperative first 30 days', 'description': 'Whether there is a correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications', 'Cancer', 'Pulmonary Complication', 'Atelectasis', 'Abdominal Surgery', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '21045639', 'type': 'BACKGROUND', 'citation': 'Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.'}, {'pmid': '28186222', 'type': 'BACKGROUND', 'citation': 'Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.'}, {'pmid': '11712875', 'type': 'BACKGROUND', 'citation': 'Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005.'}, {'pmid': '25930169', 'type': 'BACKGROUND', 'citation': 'Yang CK, Teng A, Lee DY, Rose K. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res. 2015 Oct;198(2):441-9. doi: 10.1016/j.jss.2015.03.028. Epub 2015 Mar 18.'}, {'pmid': '23287892', 'type': 'BACKGROUND', 'citation': 'Gupta H, Ramanan B, Gupta PK, Fang X, Polich A, Modrykamien A, Schuller D, Morrow LE. Impact of COPD on postoperative outcomes: results from a national database. Chest. 2013 Jun;143(6):1599-1606. doi: 10.1378/chest.12-1499.'}, {'pmid': '25058504', 'type': 'BACKGROUND', 'citation': 'Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.'}, {'pmid': '29424916', 'type': 'BACKGROUND', 'citation': 'Perilli V, Aceto P, Ancona P, De Cicco R, Papanice D, Magalini S, Pepe G, Cozza V, Gui D, Lai C, Sollazzi L. Role of surgical setting and patients-related factors in predicting the occurrence of postoperative pulmonary complications after abdominal surgery. Eur Rev Med Pharmacol Sci. 2018 Jan;22(2):547-550. doi: 10.26355/eurrev_201801_14208.'}]}, 'descriptionModule': {'briefSummary': 'The term postoperative pulmonary complication is the development of any complications affecting the respiratory system after anesthetic and surgery procedures. The ARISCAT risk assessment score is a seven-variable regression model that divides patients into low, moderate, and high-risk groups. In this study, the investigators aimed to investigate the effectiveness of the ARISCAT risk scoring index in predicting postoperative pulmonary complication development in patients scheduled for major abdominal cancer surgery.', 'detailedDescription': "Postoperative pulmonary complications (PPC) are one of the major causes of postoperative morbidity and mortality. Mortality and morbidity are 14-30% in patients with PPC, while it is 0.2-3% in patients without PPC. Its incidence is variable (\\<1% to 19%) and is more common than cardiac complications. Unfortunately, PPCs prolong the hospital stay significantly (up to 13-17 days), which means postoperative delirium, infection, and cost increase. The causes of PPCs are varied, and their physiopathology is well explained \\[3\\]. However, the rate of risk identification and scoring is not known. The synergistic effects of the patient's medical condition, general anesthesia, and surgery type on the respiratory system complicate the problem.The surgical approach, anesthesia method, and preoperative risk factors of the patients play an important role in the development of PPC.\n\nThis study was conducted after the approval from Dr. Abdurrahman Yurtaslan Oncology SUAM Ethics Committee in Ankara, Turkey (Between December 2020 - July 2021) (Ethics Committee Decision No: 2019-11 / 459). After informing all the patients included in the study, verbal and written consent were obtained. 410 patients over 18 years of age, who were scheduled for general anesthesia and whose ASA physical score was 1-4, were included in the study.\n\nDemographic data of the patients, preoperative antibiotic prophylaxis, chronic diseases, ASA scores, preoperative hemoglobulin values, functional status, history of pulmonary system disease in the last 30 days, history of smoking and the amount of cigarette consumption, history of steroid use, chemotherapy and radiotherapy history, anesthesia method, surgical incision side (lower-upper abdominal), premedication status, intraoperative ventilation parameters (tidal volume, PEEP, peak pressure, fiO2 ratio), pneumoperitoneum pressure, amount of colloid / crystalloid product used, erythrocyte suspension and amount used, laparoscopic or open surgery, emergency or elective surgery, the duration of operation, and postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) were recorded. The ARISCAT risk assessment scores of the patients were also evaluated and recorded preoperatively.\n\nThe patients were followed up in the postoperative care unit. The presence of postoperative pulmonary complications was evaluated, and the time of discharge was recorded. On the 30th day after discharge, patients were called and checked their status in terms of mortality. Postoperative pulmonary complications were defined by the development of one of the following new findings. The European Perioperative Clinical Outcome Definitions (EPCO) were used for this definition.\n\nThese findings; Respiratory Failure, Respiratory infection, Aspiration Pneumonia, Pleural effusion, Pneumothorax, Atelectasis, Bronchoconstriction, Pneumonia, ARDS, Pulmonary Embolism, Pulmonary Edema, Unplanned emergency re-intubation, Leaving as intubated from the operation room."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 420 patients operated in General Surgery, Urology, and Gynecological Oncology departments were included in the study. Seven of these patients were excluded from the study because they did not sign the written consent, and three patients were excluded due to a lack of data.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 18 years of age\n2. Who were scheduled for general anesthesia\n3. Whose ASA physical score was 1-4\n\nExclusion Criteria:\n\n1. ASA physical status\\> 4\n2. Pregnant women\n3. Intubated patients before the operation\n4. Patients who had surgery due to a previous surgical complication\n5. Severe cardiovascular disease\n6. Severe hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT04663958', 'briefTitle': 'Predictive Value of Ariscat Index In The Development of Pulmonary Complication After Major Abdominal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'Predictive Value of Ariscat Risk Index In The Development of Postoperative Pulmonary Complication After Major Abdominal Cancer Surgery', 'orgStudyIdInfo': {'id': '2019-11/459'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Detection / Screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patients were followed up in the postoperative care unit. The presence of postoperative pulmonary complications was evaluated, and the time of discharge was recorded. On the 30th day after discharge, patients were called and checked their status in terms of mortality.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Ankara', 'state': 'Yenimahalle', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'MUSTAFA KEMAL SAHIN, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mustafa Kemal ŞAHİN', 'investigatorAffiliation': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}}}}