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

February 17, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: robit-assist transperitoneal laparoscopic radical cystectomy
robit-assist radical cystectomy was performed transperitoneal
Experimental: robit-assist extraperitoneal laparoscopic radical cystectomy
robit-assist radical cystectomy was performed extraperitoneal
Procedure: robit-assist extraperitoneal laparoscopic radical cystectomy
robit-assist laparoscopic radical cystectomy was performed extraperitoneal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: through study completion, an average of 1 month, 3 month and 1 year
Complication rate after surgery
through study completion, an average of 1 month, 3 month and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 5 years after surgery
progression-free survival
5 years after surgery
OS
Time Frame: 5 years after surgery
Overall Survival
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: Lv qiang, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 3, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SR-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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