Evaluation of Hemostatic Agents in Partial Nephrectomy (HEMOSTA-PN)

Ankara University

Status: Completed

Conditions: Partial Nephrectomy; Localized Renal Cell Carcinoma; Hemostatic Agents

Treatments: Procedure: Suturing with FloSeal®; Procedure: Suturing with Surgicel®; Procedure: Standard Parenchymal Suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT07232927

İ3-191-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older.
• Diagnosed with localized renal mass (clinical stage T1a-T1b) suitable for partial nephrectomy.
• Adequate preoperative renal function to undergo surgery.
• Signed informed consent obtained prior to study enrollment.
• Undergoing open, laparoscopic, or robotic partial nephrectomy performed by the same experienced surgeon.

Exclusion criteria

• Patients with solitary kidney or bilateral renal tumors.
• History of previous renal surgery on the same kidney.
• Evidence of metastatic disease or locally advanced (≥T2) renal tumors.
• Coagulopathy, bleeding disorders, or ongoing anticoagulant therapy that cannot be discontinued.
• Active urinary tract infection or systemic infection.
• Known allergy or hypersensitivity to gelatin or oxidized cellulose components.
• Patients who decline participation or withdraw consent.
• Incomplete perioperative data or loss to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Group A - Suturing Only

Active Comparator group

Description:

Standard parenchymal suturing technique without use of adjunctive hemostatic material.

Treatment:

Procedure: Standard Parenchymal Suturing

Group B - Suturing + FloSeal®

Experimental group

Description:

Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®).

Treatment:

Procedure: Suturing with FloSeal®

Group C - Suturing + Surgicel®

Experimental group

Description:

Parenchymal suturing performed with adjunctive use of oxidized regenerated cellulose (Surgicel®).

Treatment:

Procedure: Suturing with Surgicel®