Analysis of Predictive Factors for Urinary Leakage After Partial Nephrectomy for Renal Hilum Tumors

Analysis of Predictive Factors for Urinary Leakage After Partial Nephrectomy for Renal Hilum Tumors: A Multicenter Retrospective Clinical Study

In this study, we plan to explore the risk factors closely related to the occurrence of urinary leakage after partial nephrectomy for renal hilum tumors through retrospective analysis of multicenter clinical data, thereby providing clinical guidance value for the prevention of postoperative urinary leakage.

Study Overview

• Status: Active, not recruiting
• Conditions: Partial Nephrectomy; Renal Hilum Tumors; Urinary Leakage

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • first hospital affiliated of Fujian medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing partial nephrectomy for renal hilum tumors

Description

Inclusion Criteria:

• CT or MRI angiography indicates a renal hilum tumor, and the patient has undergone partial nephrectomy;
• The Eastern Cooperative Oncology Group (ECOG) performance status score is between 0 and 1, and the age is between 18 and 75 years old;
• The clinicopathological data are complete;
• There is no infection, autoimmune disease, hematological disease, or other malignancies.

Exclusion Criteria:

• The patient has surgical contraindications;
• There are congenital malformations of the urinary system, obstructive nephropathy, or other diseases that seriously affect the function of the urinary system before surgery;
• The patient has received relevant treatments that may affect the results of this study, such as radiotherapy in the kidney area, a history of kidney surgery, etc.;
• There are tumors in both kidneys.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative urinary leakage	Postoperative urinary leakage is defined as the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.	the postoperative perirenal drainage volume being greater than 50 ml for 7 consecutive days and the creatinine level of the drainage fluid being similar to that of urine(μmol/L), or postoperative urinary leakage being suspected by imaging examination.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University
• Collaborators: The Second Affiliated Hospital of Fujian Medical University; The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): September 18, 2025
• Study Completion (Estimated): September 18, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Estimated): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: partial nephrectomy; urinary leakage; renal hilum tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MRCTA,ECFAH OfFMU[2024]905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No