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Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male

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Sun Yat-sen University

Status

Unknown

Conditions

Bladder Cancer

Treatments

Procedure: pelvic reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT04958343
SysMU-RARC4

Details and patient eligibility

About

To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.

Full description

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Enrollment

100 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male patients aged 18 or older.
  2. Patients those who are diagnosed with urothelial carcinoma.
  3. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
  4. Patients those who are able to cooperate and complete the follow-up.
  5. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion criteria

  1. Patients thsoe who are diagnosed distant metastasis before surgery.
  2. Patients those who are diagnosed with other malignancies.
  3. Patients those who had received pelvic radiotherapy or major pelvic operation.

Trial design

100 participants in 2 patient groups

reconstruction group
Description:
Patients will receive pelvic reconstruction following radical cystectomy during the operation.
Treatment:
Procedure: pelvic reconstruction
non-reconstruction group
Description:
Patients will not receive pelvic reconstruction following radical cystectomy during the operation.

Trial contacts and locations

1

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Central trial contact

Kaiwen Li, MD; Jian Huang, MD

Data sourced from clinicaltrials.gov

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