Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT04605068
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double masking (Participant, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "144 patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF)."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urethrocutaneous fistula (number & percent)', 'timeFrame': '2 years', 'description': 'Urethrocutaneous fistula'}, {'measure': 'Meatal stenosis (number & percent)', 'timeFrame': '2 years', 'description': 'Meatal stenosis'}, {'measure': 'Urethral stricture (number & percent)', 'timeFrame': '3 years', 'description': 'Urethral stricture'}], 'secondaryOutcomes': [{'measure': 'Penile rotation (number & percent)', 'timeFrame': '3 years', 'description': 'Penile rotation'}, {'measure': 'Urine stream (in caliber)', 'timeFrame': '3 years', 'description': 'Urine stream'}, {'measure': 'Urine stream (in meters)', 'timeFrame': '3 years', 'description': 'Urine stream'}, {'measure': 'Micturition time (in seconds)', 'timeFrame': '3 years', 'description': 'Micturition time'}, {'measure': 'Follow-up period (in months)', 'timeFrame': '5 years', 'description': 'Follow-up period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Penoscrotal Hypospadias', 'Chordee', 'Tubularized Double-Faced Preputial Flap', "Duckett's Urethroplasty", 'One-Stage Repair'], 'conditions': ['Hypospadias, Penoscrotal', 'Chordee']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow.", 'detailedDescription': "Type of study: RCT\n\nReview of literature:\n\n* Different modalities of urethroplasty for repair of proximal hypospadias with chordee (two-stage repair, one-stage repair, flap, graft).\n* Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..\n* Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a prospective randomized controlled study conducted at pediatric surgery department, Al-Houssain \\& New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020, on 144 male patients with penoscrotal hypospadias with chordee. Patients will be investigated by routine laboratory tests for fitness for surgery. All of them will undergo one-stage repair using either of 2 techniques of tubularized preputial flap; Duckett's versus DFPF. Written informed consent will be obtained from parents of all participants in the study.\n\nInstitutes of the study:\n\nA multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period of 6 years.\n\nEthical Consideration:\n\nThe protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for one-stage repair is respected but does not deprive the patient from getting surgical care by two-stage repair.\n\nPreoperative preparation:\n\nAll patients will be subjected to history taking, clinical examination, and necessary laboratory investigations (CBC, Coagulation profile, Liver and Renal Function tests, Electrolytes Panel, Urinalysis). They will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery. Patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF). Both techniques will be done by all members of the surgical team equally.\n\nFollow-up:\n\nPatients will be followed-up at OPD.\n\nStatistical Analysis:\n\nData were collected using a data collecting sheets (annexes) and were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM SPSS Statistics for Windows, IBM Corp, Armonk, NY, USA). Continuous variables were expressed as mean±standard deviation (SD), range, and average and categorical variables were expressed as frequency count \\& percentage. Fisher's exact test was used for comparison of frequency counts/percentage. A two-sided p-value \\< 0.05 was considered statistically significant.\n\nDiscussion:\n\nIt will focus on one-stage urethroplasty using the preputial flap for proximal hypospadias with chordee. The results obtained from this study will be compared between both group and with those reported in the literature.\n\nAlso, it will focus on results, complications, their management, and clinical evaluation by estimated urine caliber and micturition time. At the end, the investigators will conclude the reconstructive technique that gives the better results and least morbidity."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Months', 'genderBased': True, 'genderDescription': 'Male children with penoscrotal hypospadias with chordee', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncircumcised male patients with penoscrotal hypospadias,\n* rudimentary urethral plate\n* with moderate-to-severe chordee and\n* no history of previous repair\n\nExclusion Criteria:\n\n* circumcised patients,\n* patients with other types of hypospadias such as glanular or distal shaft or\n* with mild chordee corrected after penile degloving,\n* recurrent hypospadias, or\n* lost to follow-up.'}, 'identificationModule': {'nctId': 'NCT04605068', 'acronym': 'DuckettvDFPF', 'briefTitle': 'Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': "Al-Azhar Duckett's versus DFPF"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Transverse preputial island flap (Duckett's technique)", 'description': '72 patients (Group I) with penoscrotal hypospadias with chordee', 'interventionNames': ["Procedure: Transverse preputial island flap (Duckett's technique)"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double-faced preputial flap (DFPF)', 'description': '72 patients (Group II) with penoscrotal hypospadias with chordee', 'interventionNames': ['Procedure: Double-faced preputial flap (DFPF)']}], 'interventions': [{'name': "Transverse preputial island flap (Duckett's technique)", 'type': 'PROCEDURE', 'armGroupLabels': ["Transverse preputial island flap (Duckett's technique)"]}, {'name': 'Double-faced preputial flap (DFPF)', 'type': 'PROCEDURE', 'armGroupLabels': ['Double-faced preputial flap (DFPF)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohamed M Shahin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar New Damietta University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'March 2020 till indefinitely', 'ipdSharing': 'YES', 'description': 'Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature', 'accessCriteria': 'after the article became accepted and available online.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'dr. Muhammad Abdelhafez Mahmoud, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of pediatric surgery', 'investigatorFullName': 'dr. Muhammad Abdelhafez Mahmoud, MD', 'investigatorAffiliation': 'Al-Azhar University'}}}}