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).
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
- Conditions the study is for
- Partial Nephrectomy, Hemostatic Agents, Localized Renal Cell Carcinoma
- 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
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 group | Role | What they receive |
|---|---|---|
| Group A - Suturing Only | Active comparator | Standard parenchymal suturing technique without use of adjunctive hemostatic material. Receives: Procedure: Standard Parenchymal Suturing |
| Group B - Suturing + FloSeal® | Experimental | Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®). Receives: Procedure: Suturing with FloSeal® |
| Group C - Suturing + Surgicel® | Experimental | Parenchymal 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.
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
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
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)
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)
Estimated blood loss during surgery
Total blood loss recorded by anesthesia team and surgical staff.
Measured: Intraoperative (Day of surgery)
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
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.
- First posted18 Nov 2025
- Study start2 Jan 2023
- Primary completion1 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Partial NephrectomyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagri Akpinar, Ankara University
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 19683266Di 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 35407375Ljungberg 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 35346519Zargar 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 25615258Erlich 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 27431979Kola 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 39470887Maurice 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 27279548Basu 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 31040606Abu-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 27572274Aykan 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 31258357Veccia 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 30613663Tonyali 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 29277887Richter 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 12559270Gill 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 15780356Carrion 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemostatic Agents in Partial Nephrectomy: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07232927
- Acronym / sponsor ID
- HEMOSTA-PN / İ3-191-20
- Keywords
- Partial nephrectomy, Renal cell carcinoma, Hemostatic agents, FloSeal, Surgicel, Hemorrhage, Urinary leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A - Suturing Only | Active comparator | Procedure: Standard Parenchymal SuturingStandard parenchymal suturing technique without use of adjunctive hemostatic material. |
| Group B - Suturing + FloSeal® | Experimental | Procedure: Suturing with FloSeal®Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®). |
| Group C - Suturing + Surgicel® | Experimental | Procedure: Suturing with Surgicel®Parenchymal suturing performed with adjunctive use of oxidized regenerated cellulose (Surgicel®). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Parenchymal SuturingStandard parenchymal suturing technique performed during partial nephrectomy without the use of adjunctive hemostatic materials. Serves as the control arm in the study. | Procedure or surgery | Group A - Suturing Only |
| Suturing with FloSeal®Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent. | Procedure or surgery | Group B - Suturing + FloSeal® |
| Suturing with Surgicel®Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent. | Procedure or surgery | Group C - Suturing + Surgicel® |
Primary outcome
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.
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.
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.
4 secondary outcomes
Mean operative time and warm ischemia time
Time frame: Intraoperative (Day of surgery)
Estimated blood loss during surgery
Time frame: Intraoperative (Day of surgery)
Change in postoperative renal function (serum creatinine and eGFR)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 19683266Campbell 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.
- Results publication: PubMed 35407375Di 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.
- Results publication: PubMed 35346519Ljungberg 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.
- Results publication: PubMed 25615258Zargar 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.
- Results publication: PubMed 27431979Erlich 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.
- Results publication: PubMed 39470887Kola 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.
- Results publication: PubMed 27279548Maurice 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.
- Results publication: PubMed 31040606Basu 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.
- Results publication: PubMed 27572274Abu-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.
- Results publication: PubMed 31258357Aykan 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.
- Results publication: PubMed 30613663Veccia 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.
- Results publication: PubMed 29277887Tonyali 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.