Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-06 @ 3:55 AM
Study NCT ID:
NCT07243457
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2025-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Two parallel groups randomized to urethroplasty with stent (Group A) or without stent (Group B); single-center RCT at Children's Hospital Multan."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty', 'timeFrame': 'twelve weeks post operation', 'description': 'Urethrocutaneous fistula (UCF) will be determined by injecting normal saline under pressure into the terminal neourethra while compressing the penile base; visible saline spillage between two points is counted as positive. Outcome is the proportion of participants with UCF in each arm (stent vs stentless). Assessments occur at routine follow-ups (2, 6, and 12 weeks), with the primary analysis at 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urethroplasty', 'stent'], 'conditions': ['Hypospadias']}, 'referencesModule': {'references': [{'pmid': '9434004', 'type': 'RESULT', 'citation': 'Demirbilek S, Atayurt HF. One-stage hypospadias repair with stent or suprapubic diversion: which is better? J Pediatr Surg. 1997 Dec;32(12):1711-2. doi: 10.1016/s0022-3468(97)90511-x.'}, {'pmid': '8126792', 'type': 'RESULT', 'citation': 'Buson H, Smiley D, Reinberg Y, Gonzalez R. Distal hypospadias repair without stents: is it better? J Urol. 1994 Apr;151(4):1059-60. doi: 10.1016/s0022-5347(17)35180-7.'}]}, 'descriptionModule': {'briefSummary': 'Hypospadias is a birth condition in which the urine opening is on the underside of the penis. Surgery (urethroplasty) is the standard treatment. Surgeons sometimes leave a small tube ("stent") inside the new urine passage after surgery, but it is unclear whether using a stent affects the risk of a common complication called a urethrocutaneous fistula (a small leak from the new urethra to the skin).\n\nThis study will compare two routine surgical approaches for boys 1-12 years old with distal or mid-penile hypospadias who need urethroplasty: (1) surgery with a temporary stent and (2) surgery without a stent. Children will be randomly assigned to one of the two groups. All surgeries will be performed by a consultant pediatric surgeon using a standardized technique, and all children will receive usual postoperative care.\n\nFamilies will return for follow-up at 2, 6, and 12 weeks after surgery. At these visits, the team will check for fistula using a simple saline test and record any other concerns. We aim to learn which approach leads to fewer complications, less discomfort, and fewer additional procedures for children undergoing hypospadias repair.', 'detailedDescription': "Objective. To compare the incidence of urethrocutaneous fistula (UCF) after hypospadias urethroplasty performed with versus without a postoperative urethral stent. Primary endpoint: UCF at 12 weeks post-operation, defined by saline injection into the neourethra with proximal compression; visible saline spillage between two points is counted as positive.\n\nDesign and Setting. Single-center, randomized controlled trial at the Department of Pediatric Surgery, Children's Hospital Multan. Duration: 6 months from synopsis approval. Target sample size: 110 (power 80%, two-proportion test; expected UCF 13.3% with stent vs 33.3% without stent; α=0.05). Allocation by sealed opaque-envelope lottery to two parallel groups.\n\nParticipants. Inclusion: boys aged 1-12 years with distal or mid-penile hypospadias scheduled for urethroplasty. Exclusion: prior failed urethroplasty or planned staged repair. Written informed consent from parents/guardians.\n\nInterventions.\n\nGroup A (Stent urethroplasty): Standardized urethroplasty with a 6-8 Fr nasogastric tube as temporary stent (size by age). Stent removed on postoperative day 7; discharge thereafter.\n\nGroup B (Stentless urethroplasty): Standardized urethroplasty without stent; discharge on postoperative day 2.\n\nAll operations under general anesthesia by a consultant pediatric surgeon. Hemostasis with lignocaine 0.5% + adrenaline 1:200,000 (5-7 mg/kg). Repairs in 3 layers (PDS 6/0 first \\& second layers-interrupted then continuous; skin closure with Polyglactin 5/0 interrupted). Standard postoperative antibiotics and analgesia for both groups.\n\nFollow-up and Assessments. Clinic visits at 2, 6, and 12 weeks. Primary outcome (UCF) assessed with the protocolized saline test; secondary observations include general recovery and any additional interventions. Data captured on a predefined proforma.\n\nStatistical Analysis. Data analyzed in SPSS v23. Normality of numeric variables (e.g., age) by Shapiro-Wilk; age summarized as mean±SD. Categorical variables (site of hypospadias; UCF yes/no) as frequencies/percentages. Primary comparison between groups by chi-square (p\\<0.05 significant). Stratified analyses by age and hypospadias location with post-stratification chi-square (p\\<0.05).\n\nRationale and Significance. Prior comparative studies report differing UCF rates with versus without stents; this trial is designed to provide clearer evidence to guide routine practice, potentially reducing complications, discomfort, and healthcare costs for children undergoing hypospadias repair."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Boys aged 1-12 years\n\n1. Distal or mid-penile hypospadias planned for urethroplasty\n2. Parent/guardian provides written informed consent\n\nExclusion Criteria: Previous failed urethroplasty\n\n1\\. Planned staged repair'}, 'identificationModule': {'nctId': 'NCT07243457', 'acronym': 'UCFStentRCT', 'briefTitle': 'Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias', 'organization': {'class': 'OTHER_GOV', 'fullName': "Children's Hospital and Institute of Child Health, Multan"}, 'officialTitle': 'Incidence Of Urethrocutaneous Fistula Formation In Patients Undergoing Urethroplasty With And Without Stent For Hypospadias', 'orgStudyIdInfo': {'id': 'CHM-UCF-Stent-RCT-2025-01'}, 'secondaryIdInfos': [{'id': 'Punjab Health Commission', 'type': 'OTHER', 'domain': 'CHMultan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stented Urethroplasty', 'description': 'Standardized urethroplasty performed under general anesthesia with a urethral stent (6-8 Fr nasogastric tube, size by age). Repairs in 3 layers (PDS 6/0 for first/second layers; Polyglactin 5/0 for skin). Stent removed on postoperative day 7; discharge thereafter.', 'interventionNames': ['Procedure: Stent urethroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stentless Urethroplasty', 'description': 'Same standardized urethroplasty without a stent; discharge on postoperative day 2.', 'interventionNames': ['Procedure: Stentless urethroplasty']}], 'interventions': [{'name': 'Stent urethroplasty', 'type': 'PROCEDURE', 'description': 'Urethroplasty with temporary urethral stent (6-8 Fr nasogastric tube) placed intraoperatively and removed on postoperative day 7. Standardized technique: incision after infiltration with 0.5% lignocaine + adrenaline (1:200,000; 5-7 mg/kg), 3-layer repair (PDS 6/0 for first and second layers-interrupted then continuous; Polyglactin 5/0 interrupted for skin). Routine postoperative antibiotics and analgesia. Applies to Arm(s): Stent Urethroplasty (Group A).', 'armGroupLabels': ['Stented Urethroplasty']}, {'name': 'Stentless urethroplasty', 'type': 'PROCEDURE', 'description': 'Urethroplasty without urethral stent using the same standardized operative technique and peri-operative care; planned discharge on postoperative day 2. Applies to Arm(s): Stentless Urethroplasty (Group B).', 'armGroupLabels': ['Stentless Urethroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan Khurd', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'children Hospital Multan', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}], 'overallOfficials': [{'name': 'Saira Shafee, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and Institute of Child Health, Multan"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital and Institute of Child Health, Multan", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Saira Shafee', 'investigatorAffiliation': "Children's Hospital and Institute of Child Health, Multan"}}}}