Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT03503032
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2018-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of chest tube drainage', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Total duration of days patient has been having chest tube inserted in his pleural cavities'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Total duration of days patient spent in the hospital'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Total duration of days patient needed to stay in intensive care unit'}, {'measure': 'Total amount of chest tube drainage', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Total amount of chest tube drainage throughout his post operative period in ml'}, {'measure': 'Number of additional procedures', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Any additional procedures were required in the postoperative period'}, {'measure': 'Stroke', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Any post operative cerebrovascular event'}, {'measure': 'Readmissions', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of readmissions to the hospital within 30 days of discharge'}, {'measure': 'Death', 'timeFrame': 'Post operation and through 90 days of discharge from hospital', 'description': 'Death post operation and through 90 days of discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracardiac Fontan', 'Total cavo-pulmonary connection', 'Fenestrated', 'Congenital heart defects', 'Pediatrics'], 'conditions': ['Fontan Procedure']}, 'referencesModule': {'references': [{'pmid': '5089489', 'type': 'BACKGROUND', 'citation': 'Fontan F, Baudet E. Surgical repair of tricuspid atresia. Thorax. 1971 May;26(3):240-8. doi: 10.1136/thx.26.3.240.'}, {'pmid': '3184963', 'type': 'BACKGROUND', 'citation': 'de Leval MR, Kilner P, Gewillig M, Bull C. Total cavopulmonary connection: a logical alternative to atriopulmonary connection for complex Fontan operations. Experimental studies and early clinical experience. J Thorac Cardiovasc Surg. 1988 Nov;96(5):682-95.'}, {'pmid': '9434697', 'type': 'BACKGROUND', 'citation': "Amodeo A, Galletti L, Marianeschi S, Picardo S, Giannico S, Di Renzi P, Marcelletti C. Extracardiac Fontan operation for complex cardiac anomalies: seven years' experience. J Thorac Cardiovasc Surg. 1997 Dec;114(6):1020-30; discussion 1030-1. doi: 10.1016/S0022-5223(97)70016-3."}, {'pmid': '17846297', 'type': 'BACKGROUND', 'citation': "d'Udekem Y, Iyengar AJ, Cochrane AD, Grigg LE, Ramsay JM, Wheaton GR, Penny DJ, Brizard CP. The Fontan procedure: contemporary techniques have improved long-term outcomes. Circulation. 2007 Sep 11;116(11 Suppl):I157-64. doi: 10.1161/CIRCULATIONAHA.106.676445."}, {'pmid': '10892940', 'type': 'BACKGROUND', 'citation': 'Bando K, Turrentine MW, Park HJ, Sharp TG, Scavo V, Brown JW. Evolution of the Fontan procedure in a single center. Ann Thorac Surg. 2000 Jun;69(6):1873-9. doi: 10.1016/s0003-4975(00)01316-3.'}, {'pmid': '12735576', 'type': 'BACKGROUND', 'citation': 'Azakie A, Russell JL, McCrindle BW, Van Arsdell GS, Benson LN, Coles JG, Williams WG. Anatomic repair of anomalous left coronary artery from the pulmonary artery by aortic reimplantation: early survival, patterns of ventricular recovery and late outcome. Ann Thorac Surg. 2003 May;75(5):1535-41. doi: 10.1016/s0003-4975(02)04822-1.'}, {'pmid': '8601964', 'type': 'BACKGROUND', 'citation': 'de Leval MR, Dubini G, Migliavacca F, Jalali H, Camporini G, Redington A, Pietrabissa R. Use of computational fluid dynamics in the design of surgical procedures: application to the study of competitive flows in cavo-pulmonary connections. J Thorac Cardiovasc Surg. 1996 Mar;111(3):502-13. doi: 10.1016/s0022-5223(96)70302-1.'}, {'pmid': '2225370', 'type': 'BACKGROUND', 'citation': 'Bridges ND, Lock JE, Castaneda AR. Baffle fenestration with subsequent transcatheter closure. Modification of the Fontan operation for patients at increased risk. Circulation. 1990 Nov;82(5):1681-9. doi: 10.1161/01.cir.82.5.1681.'}, {'pmid': '1451248', 'type': 'BACKGROUND', 'citation': 'Bridges ND, Mayer JE Jr, Lock JE, Jonas RA, Hanley FL, Keane JF, Perry SB, Castaneda AR. Effect of baffle fenestration on outcome of the modified Fontan operation. Circulation. 1992 Dec;86(6):1762-9. doi: 10.1161/01.cir.86.6.1762.'}, {'pmid': '9386120', 'type': 'BACKGROUND', 'citation': 'Hsu DT, Quaegebeur JM, Ing FF, Selber EJ, Lamour JM, Gersony WM. Outcome after the single-stage, nonfenestrated Fontan procedure. Circulation. 1997 Nov 4;96(9 Suppl):II-335-40.'}, {'pmid': '10440170', 'type': 'BACKGROUND', 'citation': 'Thompson LD, Petrossian E, McElhinney DB, Abrikosova NA, Moore P, Reddy VM, Hanley FL. Is it necessary to routinely fenestrate an extracardiac fontan? J Am Coll Cardiol. 1999 Aug;34(2):539-44. doi: 10.1016/s0735-1097(99)00228-4.'}, {'pmid': '10892944', 'type': 'BACKGROUND', 'citation': 'Airan B, Sharma R, Choudhary SK, Mohanty SR, Bhan A, Chowdhari UK, Juneja R, Kothari SS, Saxena A, Venugopal P. Univentricular repair: is routine fenestration justified? Ann Thorac Surg. 2000 Jun;69(6):1900-6. doi: 10.1016/s0003-4975(00)01247-9.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study', 'detailedDescription': "Study Population:\n\nThis study will include all patients referred for an elective Fontan procedure at the period of the study, who demonstrated a standard risk profile. An Informed consent will be obtained from the guardians before enrollment in the investigation. All procedures followed will be in accordance with institutional guidelines.\n\nRandomization Technique:\n\nPatients will be assigned to undergo either a fenestrated or non-fenestrated Extra-cardiac Fontan, based on a table of randomly generated numbers. Preoperative clinical data will be collected and compared to ensure appropriate randomization.\n\nPreoperative Evaluation:\n\nEnrolment Criteria:\n\nPreoperative evaluation consists of ECG, transthoracic echocardiogram, and complete cardiac catheterization.\n\nPatients with the following parameters will be eligible for enrollment in the study:\n\nSinus Rhythm Atriovnetricular valve regurgitation not more than mild Aortic (neoaortic) valve regurgitation not more than mild Normal systolic dominant ventricle function Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge pressure) Pulmonary vascular resistance not more than 2 woods unit End diastolic ventricular filling pressure not more than 8 mm Hg\n\nPatient with the following will not be eligible for inclusion:\n\nPatients with pulmonary artery distortion, stenosis or thrombus requiring surgical or interventional additional procedures before or during the Fontan operation. Pacemaker insertion before or during Fontan operation. Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis. Patients for whom the cardiology/cardiac surgery case conference decision is strongly in favor of fenestration for any other cause.\n\nVentricular filling pressure will be directly measured as the end-diastolic pressure in the dominant systemic ventricle. The degree of systemic atrioventricular valve regurgitation will be assessed semi-quantitatively by echocardiographic color Doppler, primarily based on width of jet origin. The regurgitation jet will be graded as none, mild, moderate, or severe. Rhythm is assessed with preoperative ECG or Holter monitor (if required). Coil occlusion of aortopulmonary collaterals is not an exclusion criterion and is recommended before the Fontan operation.\n\nOperative Technique and postoperative management:\n\nTreatment Patients underwent an extracardiac Fontan operation. The extracardiac Fontan channel will be constructed with a Polytetrafluoroethylene (PTFE) tube graft from the inferior vena cava to the pulmonary artery. The size if the graft is determined by the surgeon and ranged from 16 to 22 mm in diameter. The fenestration consists of a single 3- to 6-mm communication between the Fontan channel and the common atrium.\n\nPostoperative treatment will include administration of captopril, and aggressive use of diuretics. All patients will receive aspirin (81 mg per day) and warfarin with a target International Normalized Ration INR of 2-2.5 beginning on the first postoperative day. To maximize caloric intake, patients ill not be fluid restricted after the initial postoperative period. All patients will be placed on fat free diet for 6 weeks. Chest tubes will be left in place until drainage is less than 5 mL/kg in a 24-hour period. A chest tube will be reinserted only if a symptomatic pleural effusion is diagnosed. Steroids and Octreotide will be started after 2 weeks of persistent drainage or immediately if Chylothorax is diagnosed biochemically.\n\nThe attending cardiologist and surgeon determined the need for and timing of postoperative cardiac catheterization. Patients will be discharged from the intensive care unit when hemodynamic and respiratory stability is ensured and a stable heart rhythm is maintained. The patients will be discharged from hospital after all chest tubes are removed and when the clinical status permits.\n\nAssessment of Outcomes:\n\nThe primary end is the total length of chest tube drainage in days. If chest tube reinsertion is required during the same admission, this time will be added to the primary outcome. Other outcome variables include length of stay in the intensive care unit, total hospital stay in days, total amount of chest tube drainage, occurrence of stroke,readmissions, reoperation, or death within 90 days of discharge. All end points are defined a priori. The day of surgery counted as day 1 for all variables. All reoperations will be assessed including returning to the operating room for bleeding or poor hemodynamics, replacement of chest tubes, cardiac catheterization, and late fenestration.\n\nStatistical Analysis:\n\nSample size estimates is based on a retrospective analysis of the last 100 patients who underwent the Fontan procedure at out institutionwith 80% power to avoid a type II statistical error. A reduction in total chest tube drainage days of 15% is considered clinically significant. The median length of chest tube drainage (estimated as one day less than the median postoperative length of hospitalization) was 19 days. Given a clinically significant difference of 15%, the calculated days of difference were 19 X 0.15 = 2.85. We set the relevant difference to be 3 days. Using a modified Lehr's equation for sample size in count data, we estimate the number in each group to be, n=4/〖(√(γ\\_1 )-√(γ\\_2 ))〗\\^2 =4/〖(√19-√16)〗\\^2 =31patients.\n\nDescriptive statistics will be calculated for all variables. Medians and ranges describe continuous variables. Categorical variables will be summarized as frequencies. The Mann Whitney U test will be used for all continuous variables; analysis and Fisher's exact test will be applied for all dichotomous variables.\n\nCount data for hospital length of stay, intensive care unit length of stay, and length of chest tube drainage will be compared by means of Poisson regression or Cox proportional hazards models. A probability value of 0.05 will indicate statistical significance. All calculations were performed with R-project statistical software (www.r-project.org)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred to King Faisal Specialist Hospital and Research Center in Jeddah for an elective (Fontan) Total cavopulmonar connection procedure at the period of the study, who demonstrated a standard risk profile.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study will includeall patients referred for an elective TCPC procedure at the period of the study, who demonstrated a standard risk profile\n* Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete cardiac catheterization.\n\nPatients with the following parameters will be eligible for enrollment in the study:\n\n* Sinus Rhythm\n* Atriovnetricular valve regurgitation not more than mild\n* Aortic (neoaortic) valve regurgitation not more than mild\n* Normal systolic dominant ventricle function\n* Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge pressure)\n* Pulmonary vascular resistance not more than 2 woods unit\n* End diastolic ventricular filling pressure not more than 8 mm Hg\n\nPatient with the following will not be eligible for inclusion:\n\n* Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or interventional additional procedures before or during the Fontan operation.\n* Pacemaker insertion before or during Fontan operation.\n* Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis.\n* Patients for whom the cardiology/cardiac surgery case conference decision is strongly in favor of fenestration for any other cause.'}, 'identificationModule': {'nctId': 'NCT03503032', 'briefTitle': 'Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Fenestrated Vs Non Fenestrated Extra-Cardiac Total Cavo-pulmonary Connection in Patients With Standard Preoperative Risk Profiles, A Prospective Randomized Study', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fenestrated', 'description': 'Standard extracardiac fontan undergoing Fontan fenestration creation', 'interventionNames': ['Procedure: Extracardiac Fontan', 'Procedure: Fontan fenestration']}, {'label': 'Non fenestrated', 'description': 'Standard extracardiac fontan without fenestration', 'interventionNames': ['Procedure: Extracardiac Fontan']}], 'interventions': [{'name': 'Extracardiac Fontan', 'type': 'PROCEDURE', 'otherNames': ['Extracardiac Total cavo-pulmonary connection'], 'description': 'Extracardiac Fontan (Total cavo-pulmonary connection) will be constructed with a tube graft from the inferior vena cava to the pulmonary artery \\[applied to both arms\\]', 'armGroupLabels': ['Fenestrated', 'Non fenestrated']}, {'name': 'Fontan fenestration', 'type': 'PROCEDURE', 'description': 'Fontan fenestration created as a single 3 to 6mm communication between fontan channel and pulmonary venous atrium \\[Fenestrated arm\\]', 'armGroupLabels': ['Fenestrated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'state': 'Westren', 'country': 'Saudi Arabia', 'facility': 'KFSHRC', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Abdulbadee Bogis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Faisal Specialist Hospital & Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}