Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05115812
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-27
First Post:
2021-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Autotransplantation; Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059228', 'term': 'Renal Nutcracker Syndrome'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D006940', 'term': 'Hyperemia'}], '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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline patient characteristics', 'timeFrame': 'January 2018 until June 2021', 'description': 'Demographics-age'}, {'measure': 'Baseline patient characteristics- BMI', 'timeFrame': 'January 2018 until June 2021', 'description': 'BMI, based on the American Society of Anesthesiologists status classification'}, {'measure': 'Baseline patient characteristics- Tobacco use', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: tobacco use'}, {'measure': 'Baseline patient characteristics- Gender', 'timeFrame': 'January 2018 until June 2021', 'description': 'Demographics: gender'}, {'measure': 'Baseline patient characteristics- Hypertension', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: hypertension'}, {'measure': 'Baseline patient characteristics- Diabetes', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: diabetes'}, {'measure': 'Baseline patient characteristics-cardiopulmonary disease', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: cardiopulmonary disease'}, {'measure': 'Baseline patient characteristics-indication for RAT (Renal Autotransplantation', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: indication for RAT (Renal Autotransplantation)'}, {'measure': 'Baseline patient characteristics-lesions', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: lesions'}, {'measure': 'Baseline patient characteristics-previous renal revascularization', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: previous renal revascularization'}, {'measure': 'Baseline patient characteristics-serum creatinine level', 'timeFrame': 'January 2018 until June 2021', 'description': 'Medical History: serum creatinine level'}, {'measure': 'short-term clinical data-Adverse events,', 'timeFrame': 'up to 30 days post discharge', 'description': 'Adverse events, re- admissions, re-operations related to the index procedure'}, {'measure': 'intraoperative characteristics-Operative time', 'timeFrame': 'January 2018 until June 2021', 'description': 'Operative time'}, {'measure': 'intraoperative characteristics-total OR time', 'timeFrame': 'January 2018 until June 2021', 'description': 'total OR time'}, {'measure': 'intraoperative characteristics-concomitant procedures', 'timeFrame': 'January 2018 until June 2021', 'description': 'concomitant procedures'}, {'measure': 'intraoperative characteristics-transfusions', 'timeFrame': 'January 2018 until June 2021', 'description': 'transfusions'}, {'measure': 'intraoperative characteristics-conversions', 'timeFrame': 'January 2018 until June 2021', 'description': 'conversions'}, {'measure': 'intraoperative characteristics-intraoperative adverse events', 'timeFrame': 'January 2018 until June 2021', 'description': 'intraoperative adverse events'}, {'measure': 'intraoperative characteristics-autotransplantation technique', 'timeFrame': 'January 2018 until June 2021', 'description': 'autotransplantation technique'}, {'measure': 'post-operative characteristics-Post-operative adverse events', 'timeFrame': 'January 2018 until June 2021', 'description': 'Post-operative adverse events'}, {'measure': 'post-operative characteristics-discharge status', 'timeFrame': 'January 2018 until June 2021', 'description': 'discharge status'}, {'measure': 'post-operative characteristics-hospital length of stay', 'timeFrame': 'January 2018 until June 2021', 'description': 'hospital length of stay'}, {'measure': 'post-operative characteristics-information on enhanced recovery program', 'timeFrame': 'January 2018 until June 2021', 'description': 'information on enhanced recovery program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Vascular Disease', 'Nutcracker Syndrome, Renal', 'Pelvic Trauma', 'Loin Pain-Hematuria Syndrome', 'Renal Tumor', 'Congestion, Venous']}, 'descriptionModule': {'briefSummary': 'Renal autotransplantation (RAT) is a method of removing a kidney from its place of origin in a patient, repairing it, and transplanting it in another location of the body, generally the iliac fossa of the same patient.RAT is a relatively new technique; the first ever RAT procedure in the US was performed in 1963. Advances in preservation and transplantation techniques have made RAT a modality that can be utilized in complex renal diseases. RAT is indicated for conditions such as renal vascular disease, nutcracker syndrome, pelvic venous congestion, pelvic trauma, refractory stone disease and, in some cases, loin pain hematuria syndrome and conventionally unresectable renal tumors.\n\nIrrespective of the excellent outcomes shown by RAT, the conventional open approach requires a large midline xiphoid-to-pubis or flank incision for donor nephrectomy with a second pelvic incision for renal transplantation into the iliac fossa.The current gold standard approach to RAT is a laparoscopic nephrectomy followed by open auto-transplantation. However, this approach still requires a large pelvic incision. Robotic technology enables us to perform more complex minimally invasive surgery. Gordon et al. performed and reported the first completely intracorporeal robotic RAT to repair a ureteral injury in 2014.', 'detailedDescription': 'This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.\n\nPerioperative and short-term clinical data will be obtained from the EMR. All the data variables will be documented in the case report forms.\n\nBecause the data will have been de-identified and is archival in nature, there will be no active subject recruitment and no patient consenting is required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject was 18 years or older at the time of the procedure\n* Subject who has undergone robotic RAT irrespective of the underlying etiology.\n\nExclusion Criteria:\n\n* Subjects who do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05115812', 'briefTitle': 'Renal Autotransplantation; Case Series', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Renal Autotransplantation; Case Series', 'orgStudyIdInfo': {'id': '025.HPB.2021.D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RAT', 'description': 'patients having undergone robotic-assisted RAT procedure', 'interventionNames': ['Procedure: Pre-Operative Information', 'Procedure: Intra-Operative Data', 'Other: Post-Operative Data (up to discharge)', 'Other: Short-Term Follow-Up Data']}], 'interventions': [{'name': 'Pre-Operative Information', 'type': 'PROCEDURE', 'description': 'Demographics (e.g., age, gender), patient characteristics (e.g., BMI, American Society of Anesthesiologists class), and pre-operative medical history (e.g., tobacco use; comorbidities: hypertension, cardiopulmonary disease, diabetes; indication for RAT; lesions; previous renal revascularization; serum creatinine level).', 'armGroupLabels': ['RAT']}, {'name': 'Intra-Operative Data', 'type': 'PROCEDURE', 'description': 'Operative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique', 'armGroupLabels': ['RAT']}, {'name': 'Post-Operative Data (up to discharge)', 'type': 'OTHER', 'description': 'Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program', 'armGroupLabels': ['RAT']}, {'name': 'Short-Term Follow-Up Data', 'type': 'OTHER', 'description': 'Adverse events, re- admissions, re-operations related to the index procedure', 'armGroupLabels': ['RAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Liver Institute of Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}