Comparison of the Application of Robot-assisted Laparoscopic Pathways in

Status Recruiting

Clinical Trial Summary

Traditional radical cystectomy (RC) is performed transabdominal. However, it often has high postoperative complications. There have been studies on extraperitoneal approach to reduce postoperative complications. Investigators divided participants underwent robot-assisted radical cystectomy into two groups (1:1) . One group of participants transabdominal, the other group extraperitoneal. The incidence of complications and PFS/OS at 3, and 5 years were compared.

Clinical Trial Description

Bladder cancer is highly prevalent worldwide and approximately 75% of these are non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC and MIBC, radical cystectomy (RC) is also the best treatment option. The traditional transperitoneal laparoscopic radical cystectomy prolapse of abdominal organs into the pelvic cavity can lead to angulation of the intestinal tract, causing obstruction. Some studies have demonstrated that the extraperitoneal route can effectively reduce these complications Currently, robot-assisted surgery technology is widely utilized in urology. Studies have demonstrated that robot-assisted total extraperitoneal cystectomy and urinary diversion are less likely to disrupt abdominal organs, particularly the intestines. Identifying and locating membrane structures and layers with anatomical significance is crucial for navigating the correct anatomic space during the operation. The using of 3D laparoscopy or a robot-assisted extraperitoneal radical cystectomy aligns more closely with the 3D membrane anatomic concept. Furthermore, for younger patients,robot-assisted extraperitoneal radical cystectomy is more favorable for preserving reproductive function. For elderly patients, it is considered more safer. Consequently, we aim to investigate whether robot-assisted extraperitoneal radical cystectomy is more advantageous for patients with MIBC or high-risk NMIBC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06253091
Study type	Interventional
Source	The First Affiliated Hospital with Nanjing Medical University
Contact	Yang Xiao Yang, MD
Phone	+86 13951813528
Email	yangxiao2915@163.com
Status	Recruiting
Phase	N/A
Start date	February 1, 2024
Completion date	December 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of the Application of Robot-assisted Laparoscopic Pathways in Radical Cystectomy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms