Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Estimated Blood loss
研究概览
简要总结
Renal function preservation is a growing concern in the surgical management of kidney tumors, particularly with the rise in chronic kidney disease worldwide. Recent surgical innovations have focused on modifying renorrhaphy techniques to minimize renal damage. Emerging evidence suggests that omitting cortical suturing may reduce operative time, blood loss, and renal parenchymal loss without increasing major complications. This randomized controlled trial aims to compare outcomes between medullary-only and combined cortical-medullary suture techniques during robot-assisted partial nephrectomy, with the goal of identifying the approach that best balances functional preservation and surgical safety.
详细描述
To investigate the clinical impact of a potentially modifiable surgical variable, namely, the choice of suture technique during renal reconstruction, on patient outcomes following robot-assisted partial nephrectomy.
The preservation of renal function has become a central concern in the surgical management of renal tumors, especially given the long-term consequences of chronic kidney disease on patient morbidity and mortality. Partial nephrectomy is preferred for localized renal masses as it allows for oncologic control while maintaining renal function. Traditionally, renorrhaphy involves a two-layer closure including both medullary and cortical sutures. However, recent literature suggests that omitting the cortical suture may reduce renal parenchymal volume loss and warm ischemia time, while possibly introducing a higher rate of minor complications.
Despite growing interest in minimally invasive nephron-sparing techniques, robust prospective and randomized trials directly comparing single-layer (medullary-only) and double-layer (cortical and medullary) renorrhaphy remain scarce. The single-layer technique, first proposed to address concerns over unnecessary cortical compression and ischemic injury, is gaining attention for its simplicity and potential advantages in reducing blood loss and operative time.
This trial aims to evaluate whether avoiding cortical suturing during robot-assisted partial nephrectomy leads to improved postoperative renal function, reduced blood loss, and shorter surgical duration. Patients will be randomly assigned to undergo either medullary-only renorrhaphy or the conventional dual-layer approach. Both techniques will be assessed for their effect on warm ischemia time, complication rates, renal volume loss, and surgical efficiency.
The study will enroll 80 patients undergoing partial nephrectomy for renal masses, distributed evenly across the two intervention groups. This sample size was calculated to ensure statistical power to detect differences in estimated blood loss, the primary outcome. A broad range of secondary outcomes will be measured at multiple postoperative time points, including estimated glomerular filtration rate, renal volume, incidence of surgical complications, and quality of life indicators.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The blinding protocol will include the patient, the physician responsible for patient selection, the physician overseeing postoperative care, the professional conducting follow-up consultations, the students involved in collecting clinical follow-up data, and the team responsible for statistical analysis. However, the surgical team and the operating surgeon will not be blinded, nor will the students responsible for collecting intraoperative data.
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
- •Diagnosis of renal mass confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
- •Indication for partial nephrectomy
- •Written informed consent
- •Expected survival of at least 6 months
- •Eastern Cooperative Oncology Group (ECOG) score performance status ≤ 1
- •Negative serum or urine pregnancy test within 24 hours before surgery for women of childbearing potential
- •Recovery from any prior therapy-related toxicity to grade 1 or better
- •If a biopsy has been performed, pathology consistent with renal cell carcinoma (RCC)
排除标准
- •Solitary kidney
- •Multiple or bilateral renal masses if more than one mass is operated on simultaneously or within less than 4 months
- •Hepatic or renal toxicity grade ≥ 2 with glomerular filtration rate (GFR) < 30 according to Common Terminology Criteria for Adverse Events (CTCAE v4)
- •Bleeding diathesis
- •Inability to maintain anticoagulation for surgery
- •Participation in another experimental trial simultaneously or within 30 days prior to enrollment
- •Significant acute or chronic medical, neurological, or psychiatric condition that could compromise safety, limit study completion, or impair study objectives in the opinion of the Principal Investigator
研究组 & 干预措施
Medullary-only suturing (single-layer)
After partial nephrectomy, only the medullary layer is sutured using a running 3-0 synthetic absorbable monofilament suture (Caproyl™). The cortical layer is not sutured. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to support hemostasis.
干预措施: Suture (Device)
Medullary-only suturing (single-layer)
After partial nephrectomy, only the medullary layer is sutured using a running 3-0 synthetic absorbable monofilament suture (Caproyl™). The cortical layer is not sutured. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to support hemostasis.
干预措施: Medullary-only suturing (single-layer) (Procedure)
Medullary and cortical suturing (two-layer)
After partial nephrectomy, both the medullary and cortical layers are sutured. The medullary layer is closed with a running 3-0 Caproyl™ suture before unclamping. Then, the cortical layer is sutured with 0 Vicryl™ using a running technique. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to assist in bleeding control.
干预措施: Medullary and cortical suturing (two-layer) (Procedure)
Medullary and cortical suturing (two-layer)
After partial nephrectomy, both the medullary and cortical layers are sutured. The medullary layer is closed with a running 3-0 Caproyl™ suture before unclamping. Then, the cortical layer is sutured with 0 Vicryl™ using a running technique. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to assist in bleeding control.
干预措施: Suture (Device)
Medullary-only suturing (single-layer)
After partial nephrectomy, only the medullary layer is sutured using a running 3-0 synthetic absorbable monofilament suture (Caproyl™). The cortical layer is not sutured. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to support hemostasis.
干预措施: Hemostatic Agent (Device)
Medullary and cortical suturing (two-layer)
After partial nephrectomy, both the medullary and cortical layers are sutured. The medullary layer is closed with a running 3-0 Caproyl™ suture before unclamping. Then, the cortical layer is sutured with 0 Vicryl™ using a running technique. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to assist in bleeding control.
干预措施: Hemostatic Agent (Device)
结局指标
主要结局
Estimated Blood loss
时间窗: Perioperative/Periprocedural time
Estimated blood loss, assessed to compare renorrhaphy techniques (single medullary suture vs. combined medullary and cortical suture) during partial nephrectomy. The volume, recorded in milliliters, was measured using a graduated collection canister connected to the assistant surgeon's suction device, with correction for the amount of saline solution instilled into the cavity.
次要结局
- Change in estimated glomerular filtration rate (eGFR)(1 day, 2 weeks, 2 months, and 5 months)
- Percentage renal volume loss(4 months)
- Warm ischemia time(Perioperative/Periprocedural time)
- Participants with intraoperative or postoperative complications(Through 5 months)
- Console time(Perioperative/Periprocedural time)
- Length of hospital stay(From the date of surgery until the date of hospital discharge, assessed up to 30 days postoperatively)
- Participants requiring intraoperative conversion(Perioperative/Periprocedural time)