Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

Sun Yat-sen University

Status: Unknown

Conditions: Bladder Cancer

Treatments: Procedure: lateral prostate capsule sparing or neurovascular bundles sparing

Study type: Interventional

Funder types: Other

Identifiers

NCT04966949

SysMU-RARC2

Details and patient eligibility

About

To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

Full description

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: nerve sparing group and lateral prostate capsule sparing group. 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 without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA<2.5ng/ml.
4. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
5. Patients those who are able to cooperate and complete the follow-up.
6. 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

lateral prostate capsule sparing group

Experimental group

Description:

Patients will be preverved the lateral prostate capsule during the resection of bladder and prostate of the operation.

Treatment:

Procedure: lateral prostate capsule sparing or neurovascular bundles sparing

nerve sparing group

Active Comparator group

Description:

Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation.

Treatment:

Procedure: lateral prostate capsule sparing or neurovascular bundles sparing