An interventional study of robit-assist extraperitoneal laparoscopic radical cystectomy in Bladder Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Exclusion Criteria:
robit-assist radical cystectomy was performed transperitoneal
robit-assist radical cystectomy was performed extraperitoneal
Procedure: robit-assist extraperitoneal laparoscopic radical cystectomy
robit-assist laparoscopic radical cystectomy was performed extraperitoneal
Complication rate
Complication rate after surgery
Time frame: through study completion, an average of 1 month, 3 month and 1 year
OS
Overall Survival
Time frame: 5 years after surgery
PFS
progression-free survival
Time frame: 5 years after surgery
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University