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

November 16, 2025 updated by: Cagri Akpinar, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06590
        • Ankara University Faculty of Medicine, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A - Suturing Only
Standard parenchymal suturing technique without use of adjunctive hemostatic material.
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.
Experimental: Group B - Suturing + FloSeal®
Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®).
Procedure: Suturing with FloSeal®
Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent.
Experimental: Group C - Suturing + Surgicel®
Parenchymal suturing performed with adjunctive use of oxidized regenerated cellulose (Surgicel®).
Procedure: Suturing with Surgicel®
Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of clinically significant postoperative hemorrhage requiring blood transfusion
Time Frame: From postoperative Day 0 through postoperative Day 30
Presence of postoperative bleeding requiring blood transfusion, radiologic, or surgical intervention, recorded according to standardized clinical criteria.
From postoperative Day 0 through postoperative Day 30
Incidence of postoperative urinary leakage or fistula
Time Frame: From postoperative Day 0 through postoperative Day 30
Detection of urinary leakage based on drain creatinine measurement or radiologic evidence of fistula following partial nephrectomy.
From postoperative Day 0 through postoperative Day 30
Rate of positive surgical margins
Time Frame: At pathological assessment (Day of surgery)
Pathologic assessment of surgical margins on resected tumor specimens to evaluate oncologic safety.
At pathological assessment (Day of surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean operative time and warm ischemia time
Time Frame: Intraoperative (Day of surgery)
Duration of surgery (skin-to-skin time) and warm ischemia time measured intraoperatively in minutes.
Intraoperative (Day of surgery)
Estimated blood loss during surgery
Time Frame: Intraoperative (Day of surgery)
Total blood loss recorded by anesthesia team and surgical staff.
Intraoperative (Day of surgery)
Change in postoperative renal function (serum creatinine and eGFR)
Time Frame: Preoperative (1 day before surgery) and postoperative Day 30
Comparison of preoperative and postoperative serum creatinine and eGFR values to assess renal function preservation.
Preoperative (1 day before surgery) and postoperative Day 30
Postoperative hospital stay
Time Frame: From postoperative Day 0 until discharge, assessed for up to 30 days.
Number of days from operation until hospital discharge.
From postoperative Day 0 until discharge, assessed for up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 27, 2024

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İ3-191-20

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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