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Robot assisted complete laparoscopic radical cystectomy + orthotopic urinary diversion: a prospective randomized controlled trial

Robot assisted complete laparoscopic radical cystectomy + orthotopic urinary diversion: a prospective randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081520
Enrollment
Unknown
Registered
2024-03-04
Start date
2023-02-23
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder tumor

Interventions

Robot assisted complete laparoscopic radical cystectomy + orthotopic urinary diversion (complete laparoscopic group) and robot assisted incomplete laparoscopic radical cystectomy + orthotopic urinary
orthotopic urinary diversion (complete laparoscopic group) and robot assisted incomplete laparoscopic radical cystectomy + orthotopic urinary diversion (incomplete laparoscopic group):the control grou

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) Age older than or equal to 18 years, sex not restricted; (2) High grade or muscle invasive bladder cancer, recurrent non muscle invasive bladder cancer, carcinoma in situ that is refractory to BCG therapy, extensive papillary disease that cannot be controlled by bladder tumor resection and intravesical bladder instillation therapy, and non urothelial bladder cancer; (3) No abnormalities in liver and kidney function; (4) Urethral sphincter and pelvic floor function normal, no anterior urethral stricture; (5) Voluntarily join in this project research and sign written informed consent. And adherence to the study protocol during the trial, including receipt of treatment and all relevant examinations, and follow-up after the end of treatment visit.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Poor general condition of patients, difficulty in tolerating anesthesia and surgical staff; (2) Had a clear history of bowel disease or (and) resection; (3) Patients had tumor invasion in bladder neck and trigone or had distant metastasis of tumor. (4) The relevant information was incomplete or no informed consent was signed.

Design outcomes

Primary

MeasureTime frame
postoperative recovery of bowel function;postoperative complication rates;volume of the neobladder;residual urine;urinary continence efficacy;

Secondary

MeasureTime frame
Operative time;intraoperative blood loss; blood transfusion rate;hospital stay;treatment costs;pain scores; postoperative recurrence of bladder tumors;quality of life;

Countries

China

Contacts

Public ContactMingxia Ding

The Second Affiliated Hospital of Kunming Medical University

dmx7166@163.com+86 137 6916 0830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026