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

Urinary Bladder Cancer Clinical Trial

Official title:

Salvage Cystectomy vs Radical Cystectomy, a Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115434
• Other study ID #: Salvage and radical cystectomy
• Status: Recruiting
• Start date: January 30, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Assiut University
• Contact: Mohamed AbdulMawgoud, MBBCH
• Phone: 1011486957
• Email: mohamedsalah003[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	?????

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View 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 Guideli — View 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 — View 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.000000000 — View 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 Uro — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative and postoperative complications of salvage and radical cystectomy.	intraoperative blood loss, quality of dissection, intestinal injury.	up to 1 year (retrospective and prospective case series)
Primary	urinary diversion	type of urinary diversion whether continent or incontinent and which type of shunt.	3 months
Secondary	quality of life of patients postoperatively	describing quality of life in patients postoperatively and how they are able to face and adapt to the new changes and requirements postoperatively	up to 3 years
Secondary	postoperative erectile function of patients	studying the effect of radical and salvage cystectomy in patients' sexual function.	up to 2 years