Nctid:
NCT06234020
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000071056", "term"=>"Anorectal Malformations"}, {"id"=>"D000000013", "term"=>"Congenital Abnormalities"}], "ancestors"=>[{"id"=>"D000004065", "term"=>"Digestive System Abnormalities"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M12", "name"=>"Congenital Abnormalities", "asFound"=>"Malformations", "relevance"=>"HIGH"}, {"id"=>"M679", "name"=>"Anorectal Malformations", "asFound"=>"Anorectal Malformations", "relevance"=>"HIGH"}, {"id"=>"M7254", "name"=>"Digestive System Abnormalities", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T3034", "name"=>"Imperforate Anus", "asFound"=>"Anorectal Malformations", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>106}, "targetDuration"=>"2 Weeks", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-01-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-07-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-07-11", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-15", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-10", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To determine the frequency of different vertebrospinal anomalies in patients with ARM", "timeFrame"=>"6 months", "description"=>"Following anomalies will be observed in patients of Anorectal Malformation:\n\n* Normal cord\n* Low lying conus\n* Thickened filum terminale\n* Tethered cord\n* Filum cyst\n* Vertebral anomalies\n* Borderline conus\n* Cervical rib (unilateral)\n* Cervical rib (bilateral)\n* Rudimentary 12th thoracic rib\n* Absent 12th thoracic rib\n* Lumbar rib\n* Syrinx\n* Ventriculus terminalis\n* Prominent central canal"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Anorectal Malformations"]}, "descriptionModule"=>{"briefSummary"=>"To determine the frequency of different vertebrospinal anomalies in patients with ARM", "detailedDescription"=>"106 pediatric patients presenting in Department of Neonatal and Paediatric Surgery, The Children Hospital, PIMS from date of approval up to 6 months with diagnosis of anorectal malforatioms will be enrolled in the study using non-probability convenience sampling technique. In this way, 106 patients will be included in the study. Patient selection will be made in the light of aforementioned exclusion and inclusion criteria of the study. Guardians of all patients will be explained about the study and informed consent will be obtained from them. Baseline data of enrolled patients will be recorded in the clinical questionnaire after careful history and examination. All patients born in our setup go through initial Xray of Lumbar spine and sacrum and ultrasound of spine which will be observed. Findings in the imaging will be noted in the clinical performa. It will be ensured that data is collected after approval of the synopsis and patient's confidentiality would not be breeched. Patients would have the autonomy to withdraw from study whenever they want."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 years", "minimumAge"=>"1 day", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients presenting in OPD, Emergency and admitted in ward.", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* I.Neonates and Paediatric patients from age 1 day to 12 years II.Presenting in Department of Paediatric Surgery with Anorectal Malformation III.Both Pre and Post Op\n\nExclusion Criteria:\n\n* Patients who have not consented for further investigations"}, "identificationModule"=>{"nctId"=>"NCT06234020", "briefTitle"=>"Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations", "organization"=>{"class"=>"OTHER", "fullName"=>"Shaheed Zulfiqar Ali Bhutto Medical University"}, "officialTitle"=>"Frequency of Vertebro-spinal Anomalies in Patients Presenting With Ano-rectal Malformations", "orgStudyIdInfo"=>{"id"=>"F.3-11/2023(ERRB)/Chairman"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal Malformation", "type"=>"OTHER", "description"=>"The patients presenting with anorectal malformation go through x-ray. We will get the reporting of x-ray done to see the vertebral anomalies and the patients presenting with fecal/urinary incontinence will go through MRI for spinal anomalies."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"44000", "city"=>"Islamabad", "country"=>"Pakistan", "facility"=>"Shaheed Zulfiqar Ali Bhutto Medical University/PIMS", "geoPoint"=>{"lat"=>33.72148, "lon"=>73.04329}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Confidentiality"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shaheed Zulfiqar Ali Bhutto Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Mansoor Ahmed", "investigatorAffiliation"=>"Shaheed Zulfiqar Ali Bhutto Medical University"}}}}
