Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT06115434
Status:
UNKNOWN
Last Update Posted:
2023-11-03
First Post:
2022-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015653', 'term': 'Cystectomy'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-29', 'studyFirstSubmitDate': '2022-11-27', 'studyFirstSubmitQcDate': '2023-10-29', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative and postoperative complications of salvage and radical cystectomy.', 'timeFrame': 'up to 1 year (retrospective and prospective case series)', 'description': 'intraoperative blood loss, quality of dissection, intestinal injury.'}, {'measure': 'urinary diversion', 'timeFrame': '3 months', 'description': 'type of urinary diversion whether continent or incontinent and which type of shunt.'}], 'secondaryOutcomes': [{'measure': 'quality of life of patients postoperatively', 'timeFrame': 'up to 3 years', 'description': 'describing quality of life in patients postoperatively and how they are able to face and adapt to the new changes and requirements postoperatively'}, {'measure': 'postoperative erectile function of patients', 'timeFrame': 'up to 2 years', 'description': "studying the effect of radical and salvage cystectomy in patients' sexual function."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['salvage', 'radical'], 'conditions': ['Urinary Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '7953264', 'type': 'RESULT', 'citation': 'Moonen LM, Horenblas S, van der Voet JC, Nuyten MJ, Bartelink H. Bladder conservation in selected T1G3 and muscle-invasive T2-T3a bladder carcinoma using combination therapy of surgery and iridium-192 implantation. Br J Urol. 1994 Sep;74(3):322-7. doi: 10.1111/j.1464-410x.1994.tb16620.x.'}, {'pmid': '27001593', 'type': 'RESULT', 'citation': 'Milowsky MI, Rumble RB, Booth CM, Gilligan T, Eapen LJ, Hauke RJ, Boumansour P, Lee CT. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016 Jun 1;34(16):1945-52. doi: 10.1200/JCO.2015.65.9797. Epub 2016 Mar 21.'}, {'pmid': '24613684', 'type': 'RESULT', 'citation': 'Ploussard G, Daneshmand S, Efstathiou JA, Herr HW, James ND, Rodel CM, Shariat SF, Shipley WU, Sternberg CN, Thalmann GN, Kassouf W. Critical analysis of bladder sparing with trimodal therapy in muscle-invasive bladder cancer: a systematic review. Eur Urol. 2014 Jul;66(1):120-37. doi: 10.1016/j.eururo.2014.02.038. Epub 2014 Feb 26.'}, {'pmid': '12118019', 'type': 'RESULT', 'citation': 'Rodel C, Grabenbauer GG, Kuhn R, Papadopoulos T, Dunst J, Meyer M, Schrott KM, Sauer R. Combined-modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002 Jul 15;20(14):3061-71. doi: 10.1200/JCO.2002.11.027.'}, {'pmid': '33617327', 'type': 'RESULT', 'citation': 'Pieretti A, Krasnow R, Drumm M, Gusev A, Dahl DM, McGovern F, Blute ML, Shipley WU, Efstathiou JA, Feldman AS, Wszolek MF. Complications and Outcomes of Salvage Cystectomy after Trimodality Therapy. J Urol. 2021 Jul;206(1):29-36. doi: 10.1097/JU.0000000000001696. Epub 2021 Feb 22.'}, {'pmid': '9681889', 'type': 'RESULT', 'citation': 'Herskind C, Bentzen SM, Overgaard J, Overgaard M, Bamberg M, Rodemann HP. Differentiation state of skin fibroblast cultures versus risk of subcutaneous fibrosis after radiotherapy. Radiother Oncol. 1998 Jun;47(3):263-9. doi: 10.1016/s0167-8140(98)00018-8.'}]}, 'descriptionModule': {'briefSummary': 'To compare operative difficulties, type of urinary diversion, intraoperative \\& postoperative complications and quality of life in patients underwent radical cystectomy and those after salvage cystectomy.', 'detailedDescription': 'Radical cystectomy is the standard treatment for muscle-invasive bladder cancer. However, in well selected patients, bladder preservation with radiotherapy and chemotherapy with maximal transurethral resection of bladder tumor (TURBT) is done. Nowadays, multiple guidelines support the use of bladder sparing therapy (BST) in the form of a trimodal therapy (TMT) as an alternative to primary RC with curative intent for selected, well-informed and compliant patients, who desire to retain their bladder. Patients usually would prefer a BST, as it is considered tolerable due to its minimal invasiveness with genuinely manageable toxicity. However, a significant proportion of patients may eventually need a salvage radical cystectomy (SV-RC) due to non-response to BST or local recurrence. Salvage cystectomy post-trimodality therapy for intravesical recurrence has an intraoperative and early complication rate comparable to primary cystectomy, Salvage cystectomy post-trimodality therapy is associated with a higher risk of overall and major late complications than primary cystectomy, Irradiated tissue presents technical and surgical challenges, as radiation can lead to an overexpression of cytokines which causes uncontrolled matrix proliferation and fibrosis These post-radiation changes lead to fixation of pelvic organs, making blunt dissection more difficult, as well as causing disruption of surgical landmarks and loss of tissue planes Another consequence of irradiated tissue is that healing is impaired and tissue is weakened, leading to the potential for wound breakdown and fistula formation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with muscle invasive bladder cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with muscle invasive bladder cancer ≥ cT2N0/xM0 who underwent salvage cystectomy / going for bladder preservation protocol.\n* patients with muscle invasive bladder cancer underwent radical cystectomy.\n\nExclusion Criteria:\n\n* Patients refusing to participate in our study.\n* patients with metastatic bladder cancer'}, 'identificationModule': {'nctId': 'NCT06115434', 'briefTitle': 'Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Salvage Cystectomy vs Radical Cystectomy, a Comparative Study', 'orgStudyIdInfo': {'id': 'Salvage and radical cystectomy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'salvage cystectomy', 'description': 'patients will undergo salvage cystectomy after failure of bladder preservation protocol', 'interventionNames': ['Procedure: cystectomy']}, {'label': 'radical cystectomy', 'description': 'patients who will undergo radical cystectomy without going through bladder preservation', 'interventionNames': ['Procedure: cystectomy']}], 'interventions': [{'name': 'cystectomy', 'type': 'PROCEDURE', 'description': 'cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.', 'armGroupLabels': ['radical cystectomy', 'salvage cystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'state': 'Asyut Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Salah', 'role': 'CONTACT', 'email': 'mohamedsalah003@gmail.com'}], 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed AbdulMawgoud, MBBCH', 'role': 'CONTACT', 'email': 'mohamedsalah003@gmail.com', 'phone': '1011486957', 'phoneExt': '+20'}, {'name': 'Mohamed Ahmed Abdelrahman, MD', 'role': 'CONTACT', 'email': 'www.mas.1990@gmail.com', 'phone': '1117858233', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal ivestigator, urology resident', 'investigatorFullName': 'Mohamed Salah Abdul Mawgoud', 'investigatorAffiliation': 'Assiut University'}}}}