NCT07232927

Evaluation of Hemostatic Agents in Partial Nephrectomy

Evaluation of Hemostatic Agents in Partial Nephrectomy: A Prospective Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomized study aims to evaluate the effect of adjunctive hemostatic agents (FloSeal® and Surgicel®) on perioperative outcomes in patients undergoing partial nephrectomy for localized renal tumors. A total of 150 patients were randomized into three groups: standard parenchymal suturing (Group A), suturing with FloSeal® (Group B), and suturing with Surgicel® (Group C). The study primarily investigates whether hemostatic agents reduce postoperative hemorrhage, urinary leakage, and positive surgical margin rates. Secondary outcomes include renal function change, operative and ischemia times, estimated blood loss, and hospital stay. All surgeries were performed by a single experienced surgeon at Ankara University Urology Department between January 2023 and December 2024.

Detailed description

Partial nephrectomy (PN) is the standard surgical treatment for localized renal tumors, providing oncologic efficacy comparable to radical nephrectomy while preserving renal function. Despite technological advances, hemorrhage and urinary leakage remain major perioperative challenges. Various hemostatic agents have been introduced to improve intraoperative hemostasis and collecting system closure, including gelatin-thrombin matrices (FloSeal®) and oxidized regenerated cellulose (Surgicel®). However, the true clinical value of these agents remains controversial due to limited high-quality evidence. This prospective, randomized, single-center trial was conducted at Ankara University Faculty of Medicine, Department of Urology. The study enrolled 150 patients with localized renal masses (clinical stage T1a-T1b) scheduled for partial nephrectomy between January 2023 and December 2024. Patients were randomized equally into three groups: Group A (suturing only), Group B (suturing with FloSeal®), and Group C (suturing with Surgicel®). All surgeries were performed by a single experienced urologic surgeon using open, laparoscopic, or robotic approaches according to tumor complexity and patient preference. The primary endpoints were the incidence of clinically significant postoperative hemorrhage requiring transfusion, urinary leakage/fistula, and oncologic safety assessed by positive surgical margins. Secondary outcomes included operative and ischemia times, estimated blood loss, postoperative renal function, and length of hospital stay. Statistical analyses included ANOVA, chi-square, logistic regression, and ROC curve analyses to identify predictors of perioperative complications and surgical margin positivity. This study provides prospective evidence that adjunctive hemostatic agents do not significantly reduce postoperative hemorrhage or urinary leakage rates and do not influence oncologic safety. Perioperative outcomes are mainly determined by tumor and surgical factors rather than the use of hemostatic materials.

Conditions

• Partial Nephrectomy
• Hemostatic Agents
• Localized Renal Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Standard Parenchymal Suturing	Standard parenchymal suturing technique performed during partial nephrectomy without the use of adjunctive hemostatic materials. Serves as the control arm in the study.
PROCEDURE	Suturing with FloSeal®	Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent.
PROCEDURE	Suturing with Surgicel®	Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent.

Timeline

• Start date: 2023-01-02
• Primary completion: 2024-12-01
• Completion: 2024-12-27
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Turkey (Türkiye)