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

NCT06115434 | Unknown DMC

• 1 other identifier: Salvage and radical cystectomy
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Bladder Cancer

Keywords

salvage; radical

Outcome Measures

Primary Outcomes (2)

• 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)

• urinary diversion

  type of urinary diversion whether continent or incontinent and which type of shunt.

  3 months

Secondary Outcomes (2)

• quality of life of patients postoperatively

  up to 3 years

• postoperative erectile function of patients

  up to 2 years

Study Arms (2)

salvage cystectomy

patients will undergo salvage cystectomy after failure of bladder preservation protocol

Procedure: cystectomy

radical cystectomy

patients who will undergo radical cystectomy without going through bladder preservation

Procedure: cystectomy

Interventions

cystectomy PROCEDURE

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

radical cystectomy; salvage cystectomy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with muscle invasive bladder cancer

You may qualify if:

• 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.

You may not qualify if:

• Patients refusing to participate in our study.
• patients with metastatic bladder cancer

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

Related Publications (6)

• 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: 7953264 RESULT

• 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: 27001593 RESULT

• 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: 24613684 RESULT

• 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: 12118019 RESULT

• 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: 33617327 RESULT

• 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.

  PMID: 9681889 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mohamed AbdulMawgoud, MBBCH

CONTACT

1011486957; mohamedsalah003@gmail.com

Mohamed Ahmed Abdelrahman, MD

CONTACT

1117858233; www.mas.1990@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal ivestigator, urology resident

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: November 3, 2023
• Study Start: January 30, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)