Clinical trial · Interventional
Evaluation of Hemostatic Agents in Partial Nephrectomy
Evaluation of Hemostatic Agents in Partial Nephrectomy: A Prospective Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemostatic Agents | — | UNRESOLVED | — |
| Localized Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Partial Nephrectomy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Parenchymal Suturing | Procedure | — | UNRESOLVED |
| Suturing with FloSeal® | Procedure | — | UNRESOLVED |
| Suturing with Surgicel® | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group A - Suturing Only
- description
- Standard parenchymal suturing technique without use of adjunctive hemostatic material.
- interventionNames
- Procedure: Standard Parenchymal Suturing
- type
- EXPERIMENTAL
- label
- Group B - Suturing + FloSeal®
- description
- Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®).
- interventionNames
- Procedure: Suturing with FloSeal®
- type
- EXPERIMENTAL
- label
- Group C - Suturing + Surgicel®
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (22)
- RESULTCampbell 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. PMID 19683266
- RESULTDi 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. PMID 35407375
- RESULTLjungberg 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
- RESULTZargar 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
- RESULTErlich 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.