Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT07283003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Postoperative Pain After Ureterorenoscopy.
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': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain assessment', 'timeFrame': 'up to 4 weeks postoperative', 'description': 'Assessment of postoperative pain will be conducted using the Visual Analogue Scale (VAS) and the study-specific mobile application HEATMAP (Byldr GmbH, Switzerland). The primary outcome is the difference between the pain scores recorded by the VAS and those recorded by the HEATMAP application at predefined postoperative time points \\[both measured on a scale from 1-10, with higher scores indicating greater pain\\].'}], 'secondaryOutcomes': [{'measure': 'Length of stay [days]', 'timeFrame': 'During the hospital stay, on average 2 days', 'description': 'Time from surgery to discharge in days \\[d\\]'}, {'measure': 'Pain Assessment', 'timeFrame': 'pre-/peri-/postoperative', 'description': 'Assessment of pain level via Visual Analogue Scale (VAS), scale \\[1-10, higher scores indicates greater pain\\]'}, {'measure': 'Pain Management', 'timeFrame': 'pre-/peri-/postoperative', 'description': 'Documentation of pain management \\[according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment\\]'}, {'measure': 'Secondary need of double-J catheter', 'timeFrame': 'up to 4 weeks postoperative', 'description': '(Please note, this applies only for patients that where in the intervention group.)\n\nPatient received a double-J catheter, binary \\[yes/no\\]'}, {'measure': 'Procedure related readmissions', 'timeFrame': 'up to 4 weeks postoperative', 'description': 'Readmission that can be linked to the URS, binary \\[Yes/No\\]'}, {'measure': 'Procedure related reoperations', 'timeFrame': 'up to 4 weeks postoperative', 'description': 'Reoperation that can be linked to the URS, binary \\[Yes/No\\]'}, {'measure': 'Comprehensive Complication Index', 'timeFrame': 'up to 4 weeks postoperative', 'description': 'Any complication that occurred within 30 days post surgery, Scale \\[from 0 (no complication) to 100 (death)\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain app evaluation', 'ureterorenoscopy', 'double-J catheter', 'pain assessment'], 'conditions': ['Ureteral Stones']}, 'descriptionModule': {'briefSummary': 'Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.', 'detailedDescription': 'After a ureteroscopy (URS) for the removal of ureteral stones, a double-J stent is routinely placed. Among other measures, this is intended to prevent pain caused by ureteral swelling, small residual fragments, blood clots, and potential drainage obstructions, which could lead to colic or fever. However, the evidence supporting the benefit of this practice is limited. At the same time, many patients report discomfort due to the stent (e.g., flank pain, dysuria, frequent urination, hematuria), which can significantly impact their quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal\n* Previous pre-stenting\n* Informed Consent as documented\n\nExclusion Criteria:\n\n* Complex ureteral conditions (e.g., known ureteral strictures)\n* Impacted stones\n* Solitary kidney\n* Patients with significant renal stones (\\>3mm)\n* Previous ureteral surgeries (except endoscopic stone treatments)\n* Pregnancy or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT07283003', 'acronym': 'STENTIMENT', 'briefTitle': 'Evaluating Postoperative Pain After Ureterorenoscopy.', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baden'}, 'officialTitle': 'Prospective Randomized Study on the Necessity of Postoperative Stenting After Ureteroscopy (URS) for Ureteral Stones.', 'orgStudyIdInfo': {'id': '2025-00665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No-Stent Group', 'description': 'No postoperative double-J catheter following ureterorenoscopy.', 'interventionNames': ['Other: No Double-J catheter insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stent Group', 'description': 'Routine postoperative double-J catheter insertion following ureterorenoscopy.', 'interventionNames': ['Procedure: Double-J catheter']}], 'interventions': [{'name': 'No Double-J catheter insertion', 'type': 'OTHER', 'description': 'Ureterorenoscopy without consecutive DJ-stent insertion.', 'armGroupLabels': ['No-Stent Group']}, {'name': 'Double-J catheter', 'type': 'PROCEDURE', 'description': 'Transurethral catheter insertion', 'armGroupLabels': ['Stent Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5404', 'city': 'Baden', 'country': 'Switzerland', 'contacts': [{'name': 'Céline Carole Kurt', 'role': 'CONTACT', 'email': 'celine.kurt@ksb.ch', 'phone': '+41 56 486 30 83'}, {'name': 'Lukas John Hefermehl, PD Dr. med.', 'role': 'CONTACT', 'email': 'lukas.hefermehl@ksb.ch', 'phone': '+41 56 486 30 92'}], 'facility': 'Kantonsspital Baden AG', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}], 'overallOfficials': [{'name': 'Lukas John Hefermehl, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Baden AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that will be recorded in this study will be available on reasonable request from the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lukas J Hefermehl', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kantonsspital Baden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lukas J Hefermehl', 'investigatorAffiliation': 'Kantonsspital Baden'}}}}