NCT06565598

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2.6 years

First QC Date

August 15, 2024

Last Update Submit

August 18, 2024

Conditions

Keywords

Laparoscopic radical nephrectomyTransperitoneal approachRobotic surgeryTubeless

Outcome Measures

Primary Outcomes (6)

  • intraoperative blood loss

    Blood loss during operation

    24 months

  • postoperative time of getting out of bed

    Time to get out of bed after surgery

    24 months

  • postoperative hospital stay

    Length of hospital stay after surgery

    2-5 Days

  • Whether to convert to laparotomy or not

    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

    Complete operative time

    1-3 Hours

  • whether the tumor was completely removed

    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 Outcomes (1)

  • Clavien-Dindo grading

    24 months

Study Arms (3)

Traditional robot-assisted transabdominal radical nephrectomy

NO INTERVENTION

Radical nephrectomy was performed through traditional robot-assisted transabdominal approach

Traditional laparoscopic transabdominal radical nephrectomy

NO INTERVENTION

Traditional laparoscopic radical nephrectomy was performed

Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy

EXPERIMENTAL

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

Interventions

Free through the single layer of the posterior abdominal cavity

Also known as: Single layer approach
Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with various causes requiring radical nephrectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First People 's Hospital of Xiushui

Jiujiang, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Baisheng Xu, Ph.D

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 22, 2024

Study Start

May 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations