Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-01-02
Study Completion Date
2024-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy
NCT03528057
Robotic-Assisted Laparoscopic Partial Nephrectomy
Hemostatic Agents
Renal Malignant Tumor
WITHDRAWN
NA
Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy
NCT04120805
Kidney Cancer
ACTIVE_NOT_RECRUITING
NA
Suturing Techniques for Vesico-urethral Anastomosis
NCT06670924
Prostate Cancer Surgery
COMPLETED
NA
LPN in Patients With High-complex Renal Tumors
NCT04933604
Renal Cancer
Renal Neoplasm
Renal Cell Carcinoma
+7 more
COMPLETED
Evaluation of Kidney Damage Using NGAL Measurements
NCT06274125
Prostatectomy
Neutrophil Gelatinase-Associated Lipocalin
Kidney Function Tests
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Partial Nephrectomy
Hemostatic Agents
Localized Renal Cell Carcinoma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - Suturing Only
Standard parenchymal suturing technique without use of adjunctive hemostatic material.
Group Type
ACTIVE_COMPARATOR
Standard Parenchymal Suturing
Intervention Type
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 B - Suturing + FloSeal®
Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®).
Group Type
EXPERIMENTAL
Suturing with FloSeal®
Intervention Type
PROCEDURE
Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent.
Group C - Suturing + Surgicel®
Parenchymal suturing performed with adjunctive use of oxidized regenerated cellulose (Surgicel®).
Group Type
EXPERIMENTAL
Suturing with Surgicel®
Intervention Type
PROCEDURE
Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Intervention Type
PROCEDURE
Suturing with FloSeal®
Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent.
Intervention Type
PROCEDURE
Suturing with Surgicel®
Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent.
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ankara University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cagri Akpinar
assistant professor of urology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara University Faculty of Medicine, Department of Urology
Ankara, Ankara, Turkey (Türkiye)
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Turkey (Türkiye)
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
RESULT
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Peyton CC, Hajiran A, Morgan K, Azizi M, Tang D, Chipollini J, Gilbert SM, Poch M, Sexton WJ, Spiess PE. Urinary leak following partial nephrectomy: a contemporary review of 975 cases. Can J Urol. 2020 Feb;27(1):10118-10124.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
İ3-191-20
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy
NCT05224024
UNKNOWN
NA
A Novel Haemostatic Agent for Robotic Partial Nephrectomy
NCT07284953
NOT_YET_RECRUITING
NA
Fluid Optimization in Liver Surgery
NCT01627808
COMPLETED
Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels
NCT03607279
COMPLETED
Comparison of Different Energy Sources During TUR-P
NCT02533687
SUSPENDED
NA
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
NCT07190638
RECRUITING
NA
Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
NCT07234968
NOT_YET_RECRUITING
NA
Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial
NCT07314853
NOT_YET_RECRUITING
NA
Off Clamp Randomization
NCT01732120
COMPLETED
NA
The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy
NCT03505112
COMPLETED
NA
EFFICACY of INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION on the POSTOPERATIVE BLOOD LOSS in PATIENTS UNDERGOING RARP for the TREATMENT of PROSTATE CANCER
NCT06822036
RECRUITING
NA
Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia
NCT05314582
COMPLETED
Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy
NCT07141225
RECRUITING
NA
Bladder Training in Radical Prostatectomy
NCT04628351
COMPLETED
NA
Development and Pilot Evaluation of a Urethral Catheter Traction Device for Post-TURP Hemorrhage Control
NCT07287488
RECRUITING
NA
Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
NCT01812902
COMPLETED
NA
Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy
NCT01836406
COMPLETED
NA
Comparison of Low and Normal Flow Anesthesia in Robotic Assisted Radical Prostatectomy
NCT05517551
UNKNOWN
Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection
NCT04185922
COMPLETED
NA
Trial of Modifications to Radical Prostatectomy
NCT01407263
ACTIVE_NOT_RECRUITING
PHASE3
Rhabdomyolysis and Robot-assisted Radical Prostatectomy
NCT02671604
COMPLETED
Comparison of the Efficacy of Perineal and Anal Electrical Stimulation in Patients with Urinary Incontinence After Radical Prostatectomy
NCT06669468
NOT_YET_RECRUITING
NA
Continence and Potency Following Multi-Layer Perinatal Issue alloGraft
NCT05081232
WITHDRAWN
NA
Bleeding After Robot-assisted Radical Prostatectomy: a Respective Study
NCT06299046
COMPLETED
PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY
NCT06502340
NOT_YET_RECRUITING