Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 8:11 AM
Study NCT ID:
NCT04869969
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2021-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supine Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074642', 'term': 'Nephrolithotomy, Percutaneous'}, {'id': 'D016683', 'term': 'Supine Position'}, {'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patients and the statistician were blinded to the type of the intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'percutaneous nephrolithotomy to be performed in both supine and prone position'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2021-03-06', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate', 'timeFrame': 'first day postoperative', 'description': 'evaluation of our patients after surgery with Xray or CT to detect residual stones'}], 'secondaryOutcomes': [{'measure': 'Fluoroscopy time during the procedure in minutes', 'timeFrame': 'intraoperative finding in minutes,', 'description': 'time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only'}, {'measure': 'operative time of the procedure in minutes', 'timeFrame': 'intraoperative finding in minutes,', 'description': 'time from patient positioning till the end of the procedure, operative finding only'}, {'measure': 'rate of Hemoglobin drop', 'timeFrame': 'day 1 post operative', 'description': 'change in the perioperative hemoglobin level'}, {'measure': 'hospital stay', 'timeFrame': 'first 2 days post surgery', 'description': 'days of hospital stay after the surgery'}, {'measure': 'incidence of urinary tract infection', 'timeFrame': 'first 7 days post surgery', 'description': 'presence of manifested urinary tract infection in our patient'}, {'measure': 'urine leakage', 'timeFrame': 'first 3 days postoperative', 'description': 'urine leakage from the percutaneous renal tract'}, {'measure': 'irrigation fluid usage', 'timeFrame': 'intraoperative finding', 'description': 'amount of irrigation fluid used during the surgery in liters'}, {'measure': 'postoperative fever', 'timeFrame': 'first 2 days post surgery', 'description': 'incidence of postoperative fever more than 38 c'}, {'measure': 'need for DJ application', 'timeFrame': 'intraoperative finding', 'description': 'the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones'}, {'measure': 'incidence of intraoperative colonic injury', 'timeFrame': 'intraoperative finding', 'description': 'the accident injury to adjacent colon'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Stone']}, 'descriptionModule': {'briefSummary': 'there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.', 'detailedDescription': 'The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury.\n\nSupine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position.\n\nour study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy\n\nExclusion Criteria:\n\n* patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention.\n* patients with skeletal abnormalities and spine deformities were also excluded\n* patients with a single kidney were also excluded'}, 'identificationModule': {'nctId': 'NCT04869969', 'briefTitle': 'Supine Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'R32/ 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'supine percutaneous nephrolithotomy', 'description': 'percutaneous nephrolithotomy to be done in the supine position', 'interventionNames': ['Procedure: percutaneous nephrolithotomy (supine position)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prone percutaneous nephrolithotomy', 'description': 'percutaneous nephrolithotomy to be done in the prone position', 'interventionNames': ['Procedure: percutaneous nephrolithotomy ( prone position)']}], 'interventions': [{'name': 'percutaneous nephrolithotomy (supine position)', 'type': 'PROCEDURE', 'description': 'percutaneous nephrolithotomy to be done in the supine position', 'armGroupLabels': ['supine percutaneous nephrolithotomy']}, {'name': 'percutaneous nephrolithotomy ( prone position)', 'type': 'PROCEDURE', 'description': 'percutaneous nephrolithotomy in the prone position', 'armGroupLabels': ['prone percutaneous nephrolithotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11367', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Ahmed Maher Gamil Ahmed Higazy', 'investigatorAffiliation': 'Ain Shams University'}}}}