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

NCT04958343 | Unknown

• 1 other identifier: SysMU-RARC4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• day-time and night-time continence rate

  Patients were considered continent when they required 0 or 1 safety pad during the day or at night.

  6 months

Secondary Outcomes (5)

• perioperative complication rate

  3 months

• operative time

  24 hours

• estimated blood loss

  24 hours

• overall survival

  1 year

• recurrence-free survival

  1 year

Study Arms (2)

reconstruction group

Patients will receive pelvic reconstruction following radical cystectomy during the operation.

Procedure: pelvic reconstruction

non-reconstruction group

Patients will not receive pelvic reconstruction following radical cystectomy during the operation.

Interventions

pelvic reconstruction PROCEDURE

After radical cystectomy, the pelvic reconstruction including the ligation of dorsal vascular complex and posterior reconstruction will be performed on patients.

reconstruction group

Eligibility Criteria

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

Study Population

Enroll patients who received RARC.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• The Seventh Affiliated Hospital of Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

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

Study Officials

• Jian Huang, MD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiwen Li, MD

CONTACT

+86-15989252628; likw6@mail.sysu.edu.cn

Jian Huang, MD

CONTACT

+86-20-81332146; huangj8@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 12, 2021
• Study Start: July 2, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)