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

NCT06916910 | Active Not Recruiting

• 1 other identifier: MRCTA,ECFAH OfFMU[2024]905
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial Nephrectomy; Renal Hilum Tumors; Urinary Leakage

Keywords

urinary leakage; partial nephrectomy; renal hilum tumors

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing partial nephrectomy for renal hilum tumors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead
• The Second Affiliated Hospital of Fujian Medical University: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, 350005, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: April 8, 2025
• Study Start: September 18, 2024
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

CN (1)