Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 6:35 PM
Study NCT ID:
NCT05144659
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2021-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics
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': '2 (Participant, Investigator) 2 masking (Participant, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '68 pediatric patients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double-faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2021-11-20', 'studyFirstSubmitQcDate': '2021-11-20', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urethrocutaneous fistula', 'timeFrame': '3 years', 'description': 'Urethrocutaneous fistula in number of cases \\&percentage'}, {'measure': 'Flap necrosis', 'timeFrame': '3 years', 'description': 'Flap necrosis in number of cases \\&percentage'}, {'measure': 'Glannular dehiscence', 'timeFrame': '3 years', 'description': 'Glannular dehiscence in number of cases \\&percentage'}, {'measure': 'Penile rotation', 'timeFrame': '3 years', 'description': 'Penile rotation in number of cases \\&percentage'}, {'measure': 'Urethral diverticulum', 'timeFrame': '3 years', 'description': 'Urethral diverticulum in number of cases \\&percentage'}], 'secondaryOutcomes': [{'measure': 'Meatal location', 'timeFrame': '3 years', 'description': 'Meatal location in number of cases'}, {'measure': 'Meatal shape', 'timeFrame': '3 years', 'description': 'Meatal shape in number of cases'}, {'measure': 'Urinary stream direction', 'timeFrame': '3 years', 'description': 'Urinary stream in number of cases'}, {'measure': 'Erection', 'timeFrame': '3 years', 'description': 'Erection straightness in number of cases'}, {'measure': 'Fistula', 'timeFrame': '3 years', 'description': 'Fistula in number of cases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Double face;', 'Onlay island flap;', 'Inner preputial flap;', 'Hypospadias in pediatrics'], 'conditions': ['Hypospadias']}, 'referencesModule': {'availIpds': [{'id': 'orcid.org/0000-0002-6328-6419', 'url': 'http://orcid.org/0000-0002-6328-6419', 'type': 'Study Protocol', 'comment': 'Upon request of data, any researcher can e-mail the investigators at daboosmohammad@gmail.com or mohamedhafez\\_82@yahoo.com and the investigators will share the required data with the researchers and will be happy for any support.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to be the most common complications, in addition to other complications, and can be attributed to the affection of flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double-faced preputial flaps.\n\nThis study aimed to evaluate double faced preputial onlay island flap technique for complication rate, outcomes for urinary stream, and cosmetic results.', 'detailedDescription': "Type of study: prospective RCT\n\nReview of literature:\n\n* Different previous techniques for the repair of various levels of penile shaft hypospadias with chordee.\n* Demonstration of two different well-established techniques for repair of anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.\n* Disadvantages of two-stage urethroplasty or technique as transverse inner preputial onlay island flap that involves dissection of the flap from its dorsal preputial tissue (as it affects the flap vascularity).\n* Merits of single-stage urethroplasty double-faced preputial onlay island flap (as it combines the benefits of vascularized pedicled flap, provides better functional and cosmetic results, and low complication rate).\n\nThis study will be conducted at pediatric surgery department at Al-Houssain and Sayed Galal University Medical Centers, in the period from May 2019 to February 2021, on 68 male patients with anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.\n\nPatients 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 urethroplasty; double-faced preputial onlay island flap versus transverse inner preputial onlay island flap.\n\nWritten informed consent will be signed by the parents of all participants in the study.\n\nInstitutes of the study: A multicenter study at pediatric surgery departments, Al-Azhar University Medical Centers in Cairo, Egypt.\n\nNumber of cases: Sixty-eight male patients. Time frame: 3 years.\n\nEthical Consideration:\n\nThe protocol will be discussed and approved by the Ethics and Institutional Review Board Committee at the investigators' hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. Written informed consent will be obtained before enrollment of the patients into the study. The family's refusal to give consent for one-stage repair is respected but does not deprive the patient of 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, Urinalysis). Participants will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery.\n\nPatients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap. All operations were done by the same surgical team.\n\nFollow-up: patients will be followed-up at OPD at 1, 3, 12, and 24 months, for incidence of any complications. HOSE score questionnaire will be used for the evaluation of outcomes.\n\nStatistical Analysis:\n\nData will be presented as mean, standard deviation, number \\& percentage. For qualitative data, Chi-square test (X2) is used to compare between the two groups and independent-samples t-test of significance is used when comparing between two means. The significance level is set at P \\<0.05. Statistical analysis will be performed using statistical package for social sciences (SPSS) version 23.0, IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA.\n\nDiscussion:\n\nIt will focus on one-stage repair for anterior, mid-penile, and posterior penile hypospadias without or with mild penile curvature using double-faced preputial onlay island flap in comparison to inner preputial onlay island flap.\n\nThe results obtained from this study will be compared between both groups and with those reported in the literature.\n\nAlso, it will focus on results, complications, their management, and clinical evaluation by Hypospadias Objective Scoring Evaluation (HOSE) questionnaire evaluation tool. Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'genderBased': True, 'genderDescription': 'Male children with anterior, mid-penile, and posterior penile hypospadias without or with mild penile curvature', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young male pediatric patients diagnosed as anterior, mid-penile, or posterior penile hypospadias\n* with shallow and narrow urethral plate measuring less than 6 millimeters,\n* without or with mild penile curvature of less than 30ยบ after degloving of the penis.\n\nExclusion Criteria:\n\n* Patients with wide urethral plate suitable for tubularized incised plate (TIP) urethroplasty,\n* other types of hypospadias as penoscrotal, scrotal, perineal hypospadias,\n* patients with moderate or severe penile curvature,\n* recurrent cases, and\n* operations done by other surgeons'}, 'identificationModule': {'nctId': 'NCT05144659', 'acronym': 'DFOF#TIOF', 'briefTitle': 'Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics.', 'orgStudyIdInfo': {'id': 'Al-Azhar DFOF versus TIOF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double faced transverse preputial onlay island flap (group A)', 'description': 'Thirty-four patients undergo double faced transverse preputial onlay island flap are categorized as (group A)', 'interventionNames': ['Procedure: Double faced transverse preputial onlay island flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transverse inner preputial onlay island flap (control group) (group B)', 'description': 'Another thirty-four patients undergo transverse inner preputial onlay island flap are categorized as the control group = (group B)', 'interventionNames': ['Procedure: Transverse inner preputial onlay island flap']}], 'interventions': [{'name': 'Double faced transverse preputial onlay island flap', 'type': 'PROCEDURE', 'description': 'A well-established one-stage repair of penile hypospadias called Double faced transverse preputial onlay island flap', 'armGroupLabels': ['Double faced transverse preputial onlay island flap (group A)']}, {'name': 'Transverse inner preputial onlay island flap', 'type': 'PROCEDURE', 'description': 'A second well-established one-stage repair of penile hypospadias called Transverse inner preputial onlay island flap', 'armGroupLabels': ['transverse inner preputial onlay island flap (control group) (group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11651', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mohammad Alsayed Daboos', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Khalid Abdelhaleem Hefney, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pediatric Surgery Department, Al-Azhar University, Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'url': 'http://orcid.org/0000-0002-6328-6419', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'November 2021 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, Faculty of Medicine, Al-Azhar University', 'investigatorFullName': 'dr. Muhammad Abdelhafez Mahmoud, MD', 'investigatorAffiliation': 'Al-Azhar University'}}}}