Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 4:19 PM
Study NCT ID:
NCT06142734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Open Pyeloplasty for Treatment of UPJO in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-09-17', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'baseline', 'description': 'From incision to last stitch'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pyeloplasty']}, 'descriptionModule': {'briefSummary': 'Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay', 'detailedDescription': 'Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Indications for surgical intervention include impaired split renal function (\\< 40%), a decrease of split renal function of \\> 10% in subsequent studies, poor drainage function after the administration of furosemide, increased anteroposterior diameter on US, and grade III and IV dilatation as defined by the Society for Fetal Urology. The open dismembered pyeloplasty was the historical gold standard repair of uretropelvic junction obstruction. Schuessler et al. introduced the first laparoscopic pyeloplasty (LP) 1993 followed by Peters et al, who performed the first pediatric laparoscopic pyeloplasty. Since then, minimally invasive pyeloplasty (MIP) -laparoscopic and robotic assisted- had an increasing interest among urologists and became widely adopted by many centers as a standard surgical intervention in UPJ obstruction; thanks to the decreased postoperative pain, short hospital stay, reduced postoperative recovery time, and comparable success rates. The high cost and long learning curve hindered generalization of MIP in all centers. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay . Tanaka et al. have reported that the benefits of laparoscopic pyeloplasty were evident only in older children . Till now 85% of infants are still treated with open pyeloplasty . According to the EAU guidelines 2023 "There does not seem to be any clear benefit of minimally invasive procedures in a very young child but current data are insufficient to defer a cut-off age " .\n\nMost of the studies that compared open to LP didn\'t limit cases to mini-incision open pyeloplasty.\n\nTo our knowledge there is no prospective randomized study comparing laparoscopic to open pyeloplasty with mini-incision in children to date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else\n\nExclusion Criteria:\n\n* Recurrent UPJ obstruction.\n* Cases that require technique other than dismembered pyeloplasty\n* Patients that have contradiction to laparoscopy.\n* comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity\n* patient refusing participation in the study.'}, 'identificationModule': {'nctId': 'NCT06142734', 'briefTitle': 'Laparoscopic Versus Open Pyeloplasty for Treatment of UPJO in Children.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Laparoscopic Versus Mini-incision Open Dismembered Pyeloplasty for Treatment of Ureteropelvic Junction Obstruction in Children: a Comparative Randomized Trial.', 'orgStudyIdInfo': {'id': 'pyeloplasty in children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'mini-incision open dismembered pyeloplasty', 'description': 'Open surgery', 'interventionNames': ['Procedure: pyeloplasty']}, {'type': 'OTHER', 'label': 'Laparoscopic dismembered pyeloplasty', 'description': 'Minimally invasive surgery', 'interventionNames': ['Procedure: pyeloplasty']}], 'interventions': [{'name': 'pyeloplasty', 'type': 'PROCEDURE', 'description': '* For laparoscopic pyeloplasty:\n* Anaesthesia: general\n* Position: a 45-degree lateral decubitus position with the concerned side up. Patient is secured to the operating table. Pneumoperitoneum is adopted through a camera port lateral to the umbilicus\n* extra operating ports are created at subcostal and at spinoumbilial line.\n* the UPJ is transperitoneally accessed by incising the white line of Toldt and the ipsilateral colon is reflected and the proximal ureter and the pelvis are identified an mobilized\n* then Anderson- Hynes pyeloplasty is carried out with insertion of nephroureterostomy or pyeloureterostomy tube.', 'armGroupLabels': ['Laparoscopic dismembered pyeloplasty', 'mini-incision open dismembered pyeloplasty']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Mahmoud Abdelraouf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Urology', 'investigatorFullName': 'Ahmed Mahmoud Abdelraouf', 'investigatorAffiliation': 'Assiut University'}}}}