Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy

August 18, 2024 updated by: The First People's Hospital of Xiushui

Observation on the Efficacy of Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy

To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, a multi-center retrospective study was conducted to evaluate the clinical efficacy of single-layer robot-assisted peritoneal retroperitoneal radical nephrectomy in patients with nephrectomy, and to compare the safety and effectiveness of traditional robot-assisted peritoneal radical nephrectomy

Study Type

Interventional

Enrollment (Estimated)

150

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 Locations

  • China
      • Jiujiang, China
        • Recruiting
        • First People 's Hospital of Xiushui
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with various causes requiring radical nephrectomy

Exclusion Criteria:

  • patients who could not tolerate laparoscopic surgery for various reasons
  • patients whose preoperative blood pressure and blood glucose were not controlled to normal
  • patients with contralateral nonfunctioning kidney or solitary kidney
  • Multiple organ surgery at the same time

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional robot-assisted transabdominal radical nephrectomy
Radical nephrectomy was performed through traditional robot-assisted transabdominal approach
No Intervention: Traditional laparoscopic transabdominal radical nephrectomy
Traditional laparoscopic radical nephrectomy was performed
Experimental: Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy
Through a single-level surgical approach, surgical robot-assisted transperitoneal retroperitoneal radical nephrectomy was performed.
Procedure: Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy
Free through the single layer of the posterior abdominal cavity
Other Names:
  • Single layer approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: 24 months
Blood loss during operation
24 months
postoperative time of getting out of bed
Time Frame: 24 months
Time to get out of bed after surgery
24 months
postoperative hospital stay
Time Frame: 2-5 Days
Length of hospital stay after surgery
2-5 Days
Whether to convert to laparotomy or not
Time Frame: 24 months
According to the surgical records in the medical records, whether the operation was converted to laparotomy was checked, and the data were recorded when collecting the data.
24 months
Operation time
Time Frame: 1-3 Hours
Complete operative time
1-3 Hours
whether the tumor was completely removed
Time Frame: 24 months
Observe whether the tumor is complete according to the naked eye after surgery，Record and record to the surgical record, record when collecting the receipt.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clavien-Dindo grading
Time Frame: 24 months
Grade I : long-term pain, fever, continuous bleeding and exudate, transient intestinal obstruction ; grade II : need blood transfusion, pneumonia ; grade III : hematuria requiring cystoscopy ; level IV : renal insufficiency requiring hemodialysis, respiratory insufficiency requiring ICU treatment, and cardiac insufficiency requiring ICU care.
24 months

Collaborators and Investigators

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

Sponsor

The First People's Hospital of Xiushui

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)

May 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSL2024005

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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