Evaluation of Hemostatic Agents in Partial Nephrectomy

NCT07232927 | Completed

• 1 other identifier: İ3-191-20
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Partial Nephrectomy; Hemostatic Agents; Localized Renal Cell Carcinoma

Keywords

Partial nephrectomy; Renal cell carcinoma; Hemostatic agents; FloSeal; Surgicel; Hemorrhage; Urinary leakage

Outcome Measures

Primary Outcomes (3)

• 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.

  From postoperative Day 0 through postoperative Day 30

• Incidence of postoperative urinary leakage or fistula

  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

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

  At pathological assessment (Day of surgery)

Secondary Outcomes (4)

• Mean operative time and warm ischemia time

  Intraoperative (Day of surgery)

• Estimated blood loss during surgery

  Intraoperative (Day of surgery)

• Change in postoperative renal function (serum creatinine and eGFR)

  Preoperative (1 day before surgery) and postoperative Day 30

• Postoperative hospital stay

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

Study Arms (3)

Group A - Suturing Only

ACTIVE COMPARATOR

Standard parenchymal suturing technique without use of adjunctive hemostatic material.

Procedure: Standard Parenchymal Suturing

Group B - Suturing + FloSeal®

EXPERIMENTAL

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

Procedure: Suturing with FloSeal®

Group C - Suturing + Surgicel®

EXPERIMENTAL

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

Procedure: Suturing with Surgicel®

Interventions

Standard Parenchymal Suturing PROCEDURE

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

Group A - Suturing Only

Suturing with FloSeal® PROCEDURE

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

Group B - Suturing + FloSeal®

Suturing with Surgicel® PROCEDURE

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

Group C - Suturing + Surgicel®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Department of Urology

Ankara, Ankara, 06590, Turkey (Türkiye)

Location

Related Publications (22)

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  PMID: 19683266 RESULT

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  PMID: 35407375 RESULT

• 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.

  PMID: 35346519 RESULT

• 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.

  PMID: 25615258 RESULT

• 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.

  PMID: 27431979 RESULT

• 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.

  PMID: 39470887 RESULT

• 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.

  PMID: 27279548 RESULT

• 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.

  PMID: 31040606 RESULT

• 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.

  PMID: 27572274 RESULT

• 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.

  PMID: 31258357 RESULT

• 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.

  PMID: 30613663 RESULT

• 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.

  PMID: 29277887 RESULT

• 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.

  PMID: 12559270 RESULT

• 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.

  PMID: 15780356 RESULT

• 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.

  PMID: 29410886 RESULT

• Shao IH, Lee CL, Lin YH, Wang HS, Chen MC, Chang YH, Sheng TW, Huang LK, Kan HC, Liu CY, Lin PH, Yu KJ, Chuang CK, Pang ST, Wu CT. Predicting hemorrhagic complications in robotic-assisted partial nephrectomy for renal tumors: simplifying risk assessment with tumor diameter and depth. J Robot Surg. 2025 Jul 10;19(1):368. doi: 10.1007/s11701-025-02537-5.

  PMID: 40637905 RESULT

• Blachman-Braun R, Patel M, Loebach L, Millan B, Saini J, Gurram S, Linehan WM, Ball MW. Urinary leak after partial nephrectomy: Insights from a cohort with hereditary, multifocal, and reoperative cases. Urol Oncol. 2025 Aug;43(8):470.e11-470.e18. doi: 10.1016/j.urolonc.2025.03.013. Epub 2025 Apr 2.

  PMID: 40180849 RESULT

• Ryan J, MacCraith E, Davis NF, McLornan L. A systematic management algorithm for perioperative complications after robotic assisted partial nephrectomy. Can Urol Assoc J. 2019 Nov;13(11):E371-E376. doi: 10.5489/cuaj.5750.

  PMID: 30817286 RESULT

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  PMID: 32065869 RESULT

• Li KP, Chen SY, Wang CY, Yang L. Comparison between minimally invasive partial nephrectomy and open partial nephrectomy for complex renal tumors: a systematic review and meta-analysis. Int J Surg. 2023 Jun 1;109(6):1769-1782. doi: 10.1097/JS9.0000000000000397.

  PMID: 37094827 RESULT

• Capitanio U, Terrone C, Antonelli A, Minervini A, Volpe A, Furlan M, Matloob R, Regis F, Fiori C, Porpiglia F, Di Trapani E, Zacchero M, Serni S, Salonia A, Carini M, Simeone C, Montorsi F, Bertini R. Nephron-sparing techniques independently decrease the risk of cardiovascular events relative to radical nephrectomy in patients with a T1a-T1b renal mass and normal preoperative renal function. Eur Urol. 2015 Apr;67(4):683-9. doi: 10.1016/j.eururo.2014.09.027. Epub 2014 Oct 3.

  PMID: 25282367 RESULT

• Cao Y, Cui Y, Li R, Tang X, Lin C, Yang X, Liu J, Zhao Q, Ma J, de Oliveira Paludo A, Schmeusser BN, Wang S, Du P. Comparing the long-term prognosis and renal function changes of partial nephrectomy (PN) and radical nephrectomy (RN) in T1 stage renal cell carcinoma patients. Transl Androl Urol. 2025 Mar 30;14(3):740-750. doi: 10.21037/tau-2025-136. Epub 2025 Mar 26.

  PMID: 40226071 RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell; Hemorrhage

Interventions

Sutures; FloSeal Matrix; Surgicel

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of urology

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 18, 2025
• Study Start: January 2, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 27, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)