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Partial NephrectomyHEMOSTA-PNNCT07232927

Evaluation of Hemostatic Agents in Partial Nephrectomy

A study testing Standard Parenchymal Suturing, Suturing with FloSeal® and Suturing with Surgicel® in people with Partial Nephrectomy and Hemostatic Agents, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard Parenchymal Suturing, Suturing with FloSeal® and Suturing with Surgicel®
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Jan 2023to 27 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara University Faculty of Medicine, Department of Urology

    Ankara, Ankara, 06590

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Standard Parenchymal Suturing, Suturing with FloSeal®, Suturing with Surgicel®
Keywords
Partial nephrectomy, Renal cell carcinoma, Hemostatic agents, FloSeal, Surgicel, Hemorrhage, Urinary leakage
Medical subject headings
Carcinoma, Renal Cell, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Parenchymal SuturingProcedure or surgery

    Standard parenchymal suturing technique performed during partial nephrectomy without the use of adjunctive hemostatic materials. Serves as the control arm in the study.

  • Suturing with FloSeal®Procedure or surgery

    Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent.

  • Suturing with Surgicel®Procedure or surgery

    Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent.

Study groups in NCT07232927
Study groupRoleWhat they receive
Group A - Suturing OnlyActive comparatorStandard parenchymal suturing technique without use of adjunctive hemostatic material.
Receives: Procedure: Standard Parenchymal Suturing
Group B - Suturing + FloSeal®ExperimentalParenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®).
Receives: Procedure: Suturing with FloSeal®
Group C - Suturing + Surgicel®ExperimentalParenchymal suturing performed with adjunctive use of oxidized regenerated cellulose (Surgicel®).
Receives: Procedure: Suturing with Surgicel®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of clinically significant postoperative hemorrhage requiring blood transfusion

    Presence of postoperative bleeding requiring blood transfusion, radiologic, or surgical intervention, recorded according to standardized clinical criteria.

    Measured: From postoperative Day 0 through postoperative Day 30

  2. Incidence of postoperative urinary leakage or fistula

    Detection of urinary leakage based on drain creatinine measurement or radiologic evidence of fistula following partial nephrectomy.

    Measured: From postoperative Day 0 through postoperative Day 30

  3. Rate of positive surgical margins

    Pathologic assessment of surgical margins on resected tumor specimens to evaluate oncologic safety.

    Measured: At pathological assessment (Day of surgery)

Secondary outcomes (4)
  1. Mean operative time and warm ischemia time

    Duration of surgery (skin-to-skin time) and warm ischemia time measured intraoperatively in minutes.

    Measured: Intraoperative (Day of surgery)

  2. Estimated blood loss during surgery

    Total blood loss recorded by anesthesia team and surgical staff.

    Measured: Intraoperative (Day of surgery)

  3. Change in postoperative renal function (serum creatinine and eGFR)

    Comparison of preoperative and postoperative serum creatinine and eGFR values to assess renal function preservation.

    Measured: Preoperative (1 day before surgery) and postoperative Day 30

  4. Postoperative hospital stay

    Number of days from operation until hospital discharge.

    Measured: From postoperative Day 0 until discharge, assessed for up to 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start2 Jan 2023
  3. Primary completion1 Dec 2024
  4. Study completion27 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, randomized, single-center, three-arm, parallel assignment clinical trial comparing standard parenchymal suturing (Group A), suturing with FloSeal® (Group B), and suturing with Surgicel® (Group C) during partial nephrectomy for localized renal tumors.
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232927
Sponsor's protocol ID
İ3-191-20
Acronym
HEMOSTA-PN
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Campbell SC, Novick AC, Belldegrun A, Blute ML, Chow GK, Derweesh IH, Faraday MM, Kaouk JH, Leveillee RJ, Matin SF, Russo P, Uzzo RG; Practice Guidelines Committee of the American Urological Association. Guideline for management of the clinical T1 renal mass. J Urol. 2009 Oct;182(4):1271-9. doi: 10.1016/j.juro.2009.07.004. Epub 2009 Aug 14. No abstract available.

    PubMed 19683266
  • Di Maida F, Campi R, Lane BR, De Cobelli O, Sanguedolce F, Hatzichristodoulou G, Antonelli A, Grosso AA, Noyes S, Rodriguez-Faba O, Keeley FX, Langenhuijsen J, Musi G, Klatte T, Roscigno M, Akdogan B, Furlan M, Simeone C, Karakoyunlu N, Marszalek M, Capitanio U, Volpe A, Brookman-May S, Gschwend JE, Smaldone MC, Uzzo RG, Kutikov A, Minervini A, Sib International Consortium. Predictors of Positive Surgical Margins after Robot-Assisted Partial Nephrectomy for Localized Renal Tumors: Insights from a Large Multicenter International Prospective Observational Project (The Surface-Intermediate-Base Margin Score Consortium). J Clin Med. 2022 Mar 23;11(7):1765. doi: 10.3390/jcm11071765.

    PubMed 35407375
  • Ljungberg B, Albiges L, Abu-Ghanem Y, Bedke J, Capitanio U, Dabestani S, Fernandez-Pello S, Giles RH, Hofmann F, Hora M, Klatte T, Kuusk T, Lam TB, Marconi L, Powles T, Tahbaz R, Volpe A, Bex A. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2022 Update. Eur Urol. 2022 Oct;82(4):399-410. doi: 10.1016/j.eururo.2022.03.006. Epub 2022 Mar 26.

    PubMed 35346519
  • Zargar H, Khalifeh A, Autorino R, Akca O, Brandao LF, Laydner H, Krishnan J, Samarasekera D, Haber GP, Stein RJ, Kaouk JH. Urine leak in minimally invasive partial nephrectomy: analysis of risk factors and role of intraoperative ureteral catheterization. Int Braz J Urol. 2014 Nov-Dec;40(6):763-71. doi: 10.1590/S1677-5538.IBJU.2014.06.07.

    PubMed 25615258
  • Erlich T, Abu-Ghanem Y, Ramon J, Mor Y, Rosenzweig B, Dotan Z. Postoperative Urinary Leakage Following Partial Nephrectomy for Renal Mass: Risk Factors and a Proposed Algorithm for the Diagnosis and Management. Scand J Surg. 2017 Jun;106(2):139-144. doi: 10.1177/1457496916659225. Epub 2016 Jul 18.

    PubMed 27431979
  • Kola O, Smigelski M, Nagpal S, Gogaj R, Taneja SS, Wysock JS, Huang WC. Urine leak and vascular complications following robotic partial nephrectomy: a contemporary single-center experience. J Robot Surg. 2024 Oct 29;18(1):387. doi: 10.1007/s11701-024-02096-1.

    PubMed 39470887
  • Maurice MJ, Ramirez D, Kara O, Malkoc E, Nelson RJ, Caputo PA, Kaouk JH. Omission of Hemostatic Agents During Robotic Partial Nephrectomy Does Not Increase Postoperative Bleeding Risk. J Endourol. 2016 Aug;30(8):877-83. doi: 10.1089/end.2016.0192.

    PubMed 27279548
  • Basu S, Khan IA, Das RK, Dey RK, Khan D, Agarwal V. RENAL nephrometry score: Predicting perioperative outcomes following open partial nephrectomy. Urol Ann. 2019 Apr-Jun;11(2):187-192. doi: 10.4103/UA.UA_93_18.

    PubMed 31040606
  • Abu-Ghanem Y, Dotan Z, Kaver I, Zilberman DE, Ramon J. The use of Haemostatic Agents does not impact the rate of hemorrhagic complications in patients undergoing partial nephrectomy for renal masses. Sci Rep. 2016 Aug 30;6:32376. doi: 10.1038/srep32376.

    PubMed 27572274
  • Aykan S, Temiz MZ, Ulus I, Yilmaz M, Gonultas S, Suzan S, Semercioz A, Muslumanoglu AY. The Use of Three Different Hemostatic Agents during Laparoscopic Partial Nephrectomy: A Comparison of Surgical and Early Renal Functional Outcomes. Eurasian J Med. 2019 Jun;51(2):160-164. doi: 10.5152/eurasianjmed.2018.18293.

    PubMed 31258357
  • Veccia A, Autorino R. Is there a relation between preserved renal function and oncological outcomes in patients undergoing partial nephrectomy for renal cell carcinoma? Ann Transl Med. 2018 Nov;6(Suppl 1):S88. doi: 10.21037/atm.2018.11.01. No abstract available.

    PubMed 30613663
  • Tonyali S, Koni A, Yazici S, Bilen CY. The Safety and Efficacy of Adjuvant Hemostatic Agents During Laparoscopic Nephron-Sparing Surgery: Comparison of Tachosil and Floseal Versus No Hemostatic Agents. Urol J. 2017 Jan 23;15(1):21-25. doi: 10.22037/uj.v0i0.4090.

    PubMed 29277887
  • Richter F, Schnorr D, Deger S, Trk I, Roigas J, Wille A, Loening SA. Improvement of hemostasis in open and laparoscopically performed partial nephrectomy using a gelatin matrix-thrombin tissue sealant (FloSeal). Urology. 2003 Jan;61(1):73-7. doi: 10.1016/s0090-4295(02)02143-x.

    PubMed 12559270
  • Gill IS, Ramani AP, Spaliviero M, Xu M, Finelli A, Kaouk JH, Desai MM. Improved hemostasis during laparoscopic partial nephrectomy using gelatin matrix thrombin sealant. Urology. 2005 Mar;65(3):463-6. doi: 10.1016/j.urology.2004.10.030.

    PubMed 15780356
  • Carrion DM, Y Gregorio SA, Rivas JG, Bazan AA, Sebastian JD, Martinez-Pineiro L. The role of hemostatic agents in preventing complications in laparoscopic partial nephrectomy. Cent European J Urol. 2017;70(4):362-367. doi: 10.5173/ceju.2017.1432. Epub 2017 Oct 17.

    PubMed 29410886

Questions about this trial

What is this clinical trial studying?

A study testing Standard Parenchymal Suturing, Suturing with FloSeal® and Suturing with Surgicel® in people with Partial Nephrectomy and Hemostatic Agents, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of clinically significant postoperative hemorrhage requiring blood transfusion (time frame: From postoperative Day 0 through postoperative Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232927, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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