Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT04970160
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2021-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rectovestibular Fistula Which Surgical Approaches?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071056', 'term': 'Anorectal Malformations'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Templeton score', 'timeFrame': '1 year', 'description': 'The follow up period is up to one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (\\<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score\n\n. It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.'}], 'secondaryOutcomes': [{'measure': 'Anal continence', 'timeFrame': '1year', 'description': 'The assessment period is upto one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (\\<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score3\n\n. It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular anus,', 'Anal transposition,', 'Anorectal malformations', 'Transfistula anorectoplasty'], 'conditions': ['Vestibular Fistulae']}, 'descriptionModule': {'briefSummary': 'This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.', 'detailedDescription': 'Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The investigator compared four different operative techniques in terms of postoperative complications, continence, and cosmetic appearance. Patients and methods: This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study was a randomized, comparative trial involving female children suffering from vestibular fistula taken from among patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital from January 2016 to February 2020. The patients were randomly separated into four groups according to the procedure performed. The different procedures included were TSARP, PSARP, classic ASARP, and modified ASARP. Randomization did by copies the names of the techniques on four separate papers and then the surgeon was blindly chose one paper for each patient. Four pediatric surgeons had experience in ARMs techniques were performed the repair.', 'genderDescription': 'Female children with rectovestibular fistula', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female children aged 6 months to 12 years who had rectovestibular fistulae that had been treated by a single-stage repair were included in this study.\n\nExclusion Criteria:\n\n* Exclusion criteria were patients with recurrence, previous anorectal surgery.\n* Patients with anovestibular fistulae.\n* Patients with rectoperineal fistulas.\n* Patients with cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT04970160', 'acronym': 'Vestibanus', 'briefTitle': 'Rectovestibular Fistula Which Surgical Approaches?', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Rectovestibular Fistula Which Surgical Approaches?', 'orgStudyIdInfo': {'id': 'AswanUH2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TSARP', 'description': 'Is a surgical procedure', 'interventionNames': ['Procedure: TSARP']}, {'label': 'ASARP classic', 'description': 'Surgical procedure', 'interventionNames': ['Procedure: Classic ASARP']}, {'label': 'PSARP', 'description': 'Surgical procedure', 'interventionNames': ['Procedure: PSARP']}, {'label': 'Modified ASARP', 'description': 'Surgical procedure', 'interventionNames': ['Procedure: Modified ASARP']}], 'interventions': [{'name': 'TSARP', 'type': 'PROCEDURE', 'otherNames': ['Transfistula anorectoplasty TFARP'], 'description': 'We make four different surgical operations for female patients with rectovestibular fistula', 'armGroupLabels': ['TSARP']}, {'name': 'PSARP', 'type': 'PROCEDURE', 'otherNames': ['Posterior sagittal anorectoplasty'], 'description': 'Posterior sagittal anorectoplasty', 'armGroupLabels': ['PSARP']}, {'name': 'Classic ASARP', 'type': 'PROCEDURE', 'otherNames': ['Anterior Sagittal anorectoplasty'], 'description': 'Anterior Sagittal anorectoplasty', 'armGroupLabels': ['ASARP classic']}, {'name': 'Modified ASARP', 'type': 'PROCEDURE', 'otherNames': ['External anal sphincter preservation'], 'description': 'External anal sphincter preservation', 'armGroupLabels': ['Modified ASARP']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sarah Abdelmohsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Magdy', 'investigatorAffiliation': 'Aswan University Hospital'}}}}