Evaluation of Hemostatic Agents in Partial Nephrectomy: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of clinically significant postoperative hemorrhage requiring blood transfusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A - Suturing Only
Standard parenchymal suturing technique without use of adjunctive hemostatic material.
干预措施: Standard Parenchymal Suturing (Procedure)
Group B - Suturing + FloSeal®
Parenchymal suturing performed with adjunctive application of gelatin-thrombin matrix (FloSeal®).
干预措施: Suturing with FloSeal® (Procedure)
Group C - Suturing + Surgicel®
Parenchymal suturing performed with adjunctive use of oxidized regenerated cellulose (Surgicel®).
干预措施: Suturing with Surgicel® (Procedure)
结局指标
主要结局
Incidence of clinically significant postoperative hemorrhage requiring blood transfusion
时间窗: 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
时间窗: 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
时间窗: At pathological assessment (Day of surgery)
Pathologic assessment of surgical margins on resected tumor specimens to evaluate oncologic safety.
Incidence of clinically significant postoperative hemorrhage requiring blood transfusion
时间窗: 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
时间窗: 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
时间窗: At pathological assessment (Day of surgery)
Pathologic assessment of surgical margins on resected tumor specimens to evaluate oncologic safety.
次要结局
- Mean operative time and warm ischemia time(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.)
- Estimated blood loss during surgery(Intraoperative (Day of surgery))
- Postoperative hospital stay(From postoperative Day 0 until discharge, assessed for up to 30 days.)
- 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)
研究者
Cagri Akpinar
assistant professor of urology
Ankara University