Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy

NCT ID: NCT06115434

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Bladder Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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salvage cystectomy

patients will undergo salvage cystectomy after failure of bladder preservation protocol

cystectomy

Intervention Type PROCEDURE

cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.

radical cystectomy

patients who will undergo radical cystectomy without going through bladder preservation

cystectomy

Intervention Type PROCEDURE

cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.

Interventions

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cystectomy

cystectomy either radical or salvage involves removal of urinary bladder together with prostate, seminal vesicles and urethra with lymph node dissection.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with muscle invasive bladder cancer ≥ cT2N0/xM0 who underwent salvage cystectomy / going for bladder preservation protocol.
* patients with muscle invasive bladder cancer underwent radical cystectomy.

Exclusion Criteria

* Patients refusing to participate in our study.
* patients with metastatic bladder cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Salah Abdul Mawgoud

principal ivestigator, urology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university hospital

Asyut, Asyut Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed AbdulMawgoud, MBBCH

Role: CONTACT

1011486957 ext. +20

Mohamed Ahmed Abdelrahman, MD

Role: CONTACT

1117858233 ext. +20

Facility Contacts

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Mohamed Salah

Role: primary

References

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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.

Reference Type RESULT
PMID: 7953264 (View on PubMed)

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.

Reference Type RESULT
PMID: 27001593 (View on PubMed)

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.

Reference Type RESULT
PMID: 24613684 (View on PubMed)

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.

Reference Type RESULT
PMID: 12118019 (View on PubMed)

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.

Reference Type RESULT
PMID: 33617327 (View on PubMed)

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.

Reference Type RESULT
PMID: 9681889 (View on PubMed)

Other Identifiers

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Salvage and radical cystectomy

Identifier Type: -

Identifier Source: org_study_id

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