Hemostatic Agents, Localized Renal Cell Carcinoma, Partial Nephrectomy
Conditions
Keywords
Partial nephrectomy, Renal cell carcinoma, Hemostatic agents, FloSeal, Surgicel, Hemorrhage, Urinary leakage
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.
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.
Interventions
PROCEDUREStandard 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.
PROCEDURESuturing with FloSeal®
Partial nephrectomy performed with parenchymal suturing combined with gelatin-thrombin matrix (FloSeal®) as an adjunctive hemostatic agent.
PROCEDURESuturing with Surgicel®
Partial nephrectomy performed with parenchymal suturing combined with oxidized regenerated cellulose (Surgicel®) as an adjunctive hemostatic agent.
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant postoperative hemorrhage requiring blood transfusion | 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 | 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 | At pathological assessment (Day of surgery) | Pathologic assessment of surgical margins on resected tumor specimens to evaluate oncologic safety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean operative time and warm ischemia time | Intraoperative (Day of surgery) | Duration of surgery (skin-to-skin time) and warm ischemia time measured intraoperatively in minutes. |
| Postoperative hospital stay | From postoperative Day 0 until discharge, assessed for up to 30 days. | Number of days from operation until hospital discharge. |
| Estimated blood loss during surgery | Intraoperative (Day of surgery) | Total blood loss recorded by anesthesia team and surgical staff. |
| Change in postoperative renal function (serum creatinine and eGFR) | Preoperative (1 day before surgery) and postoperative Day 30 | Comparison of preoperative and postoperative serum creatinine and eGFR values to assess renal function preservation. |
Countries
Turkey (Türkiye)
Outcome results
None listed