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

NCT06253091 | Recruiting

• 1 other identifier: 2023-SR-017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

radical cystectomy

Outcome Measures

Primary Outcomes (1)

• Complication rate

  Complication rate after surgery

  through study completion, an average of 1 month, 3 month and 1 year

Secondary Outcomes (2)

• OS

  5 years after surgery

• PFS

  5 years after surgery

Study Arms (2)

robit-assist transperitoneal laparoscopic radical cystectomy

NO INTERVENTION

robit-assist radical cystectomy was performed transperitoneal

robit-assist extraperitoneal laparoscopic radical cystectomy

EXPERIMENTAL

robit-assist radical cystectomy was performed extraperitoneal

Procedure: robit-assist extraperitoneal laparoscopic radical cystectomy

Interventions

robit-assist extraperitoneal laparoscopic radical cystectomy PROCEDURE

robit-assist laparoscopic radical cystectomy was performed extraperitoneal

robit-assist extraperitoneal laparoscopic radical cystectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Researchers evaluated patients with muscle invasive bladder cancer or high-risk non-muscular invasive bladder cancer who needed radical cystectomy.
• 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;
• None of the pastHistory of abdominal surgery;
• to 75 years old;
• ECOG physical state 0 or 1;
• 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;

You may not qualify if:

• Patients who refuse to receive radical cystectomy
• Researchers evaluate patients who are unable to tolerate radical cystectomy;
• There is a abdominal history of surgery;
• Have had a large-scale operation or major trauma within 28 days before joining the group;
• Have been vaccinated with live vaccine within 28 days before joining the group;
• Severe chronic or active infection that requires systemic anti-bacterial, antifungal or antiviral treatment within 14 days before joining the group;
• Participating in the rest of the clinical research.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (22)

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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

• Lv qiang, PhD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Yang Xiao Yang, MD

CONTACT

+86 13951813528; yangxiao2915@163.com

bai rongjie

CONTACT

+86 15151211913; bai_rongjie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 12, 2024
• Study Start: February 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)