Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy

Not Applicable

Recruiting

• Conditions: Renal Cancer; Nonfunctional Kidney
• Interventions: Procedure: Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy

• Registration Number: NCT06565598
• Lead Sponsor: The First People's Hospital of Xiushui

Brief Summary

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

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 Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-18
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy	Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy	Through a single-level surgical approach, surgical robot-assisted transperitoneal retroperitoneal radical nephrectomy was performed.

Primary Outcome Measures

Name	Time	Method
postoperative hospital stay	2-5 Days	Length of hospital stay after surgery
whether the tumor was completely removed	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.
Operation time	1-3 Hours	Complete operative time
Whether to convert to laparotomy or not	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.
intraoperative blood loss	24 months	Blood loss during operation
postoperative time of getting out of bed	24 months	Time to get out of bed after surgery

Secondary Outcome Measures

Name	Time	Method
Clavien-Dindo grading	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.

Trial Locations

Locations (1)

First People 's Hospital of Xiushui; 🇨🇳 Jiujiang, China