To hear about similar clinical trials, please enter your email below
Trial Title:
Comparison of the Application of Robot-assisted Laparoscopic Pathways in Radical Cystectomy
NCT ID:
NCT06253091
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
radical cystectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
robit-assist extraperitoneal laparoscopic radical cystectomy
Description:
robit-assist laparoscopic radical cystectomy was performed extraperitoneal
Arm group label:
robit-assist extraperitoneal laparoscopic radical cystectomy
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Researchers evaluated patients with muscle invasive bladder cancer or high-risk
non-muscular invasive bladder cancer who needed radical cystectomy.
2. Willing to accept the operation and meet the surgical index: a) Absolute count of
neutrophils≥1.5x109/L; b) Platelets≥100×109/L; c) Hemoglobin≥90g/L; d) International
standardized ratio or activationPartial thrombin time≤1.5 Upper limit of normal
value (ULN); e) calculated creatinine clearance rate≥1 ml/s; f) Total serum
bilirubin≤1.5×ULN; g) AST, ALT and alkaline phosphatase≤2.5×ULN; h) Cardiopulmonary
function indicates that it can tolerate major abdominal surgery;
3. None of the pastHistory of abdominal surgery;
4. 18 to 75 years old;
5. ECOG physical state 0 or 1;
6. voluntarily participate in this experiment, be able to provide a written version of
the informed consent, and be able to understand and agree to comply with the
requirements of this study and the evaluation schedule;
Exclusion Criteria:
1. Patients who refuse to receive radical cystectomy
2. Researchers evaluate patients who are unable to tolerate radical cystectomy;
3. There is a abdominal history of surgery;
4. Have had a large-scale operation or major trauma within 28 days before joining the
group;
5. Have been vaccinated with live vaccine within 28 days before joining the group;
6. Severe chronic or active infection that requires systemic anti-bacterial, antifungal
or antiviral treatment within 14 days before joining the group;
7. Participating in the rest of the clinical research.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Lu, PhD
Phone:
13505196501
Email:
dxhlvqiang@163.com
Contact backup:
Last name:
Pengchao Li, PhD
Phone:
13584025756
Email:
superkulian@aliyun.com
Start date:
February 1, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06253091
