Standard Flank Approach vs Supine Approach for Robot-assisted Partial Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- TRIFECTA
研究概览
简要总结
This study aims to find out which surgical position is safer and works better for patients candidate to robot-assisted partial nephrectomy (RAPN) - a minimally invasive procedure to remove a small kidney tumor while preserving healthy kidney tissue.
During this operation, the patient can be placed in two different positions:
- the standard flank position, where the patient lies on their side
- a newer supine position, where the patient lies on their back using a technique called Supine Anterior Retroperitoneal Approach (SARA).
Both approaches are performed using the Da Vinci® Single Port (SP) robotic system, a state-of-the-art surgical robot that allows the operation to be done through a single small incision.
The traditional flank position has been used for many years, but it can be uncomfortable for patients and may increase the risk of certain anesthetic or nerve-related complications, especially in people with higher body weight. The new supine SARA technique could make surgery faster, safer, and less painful, but it has not yet been tested in a randomized study.
This is the first clinical trial designed to directly compare these two approaches in patients with small and localized kidney cancers (tumors ≤7 cm, stage cT1).
The study will include 124 patients treated at ASST Grande Ospedale Metropolitano Niguarda in Milan, Italy - a leading center in robotic urologic surgery.
详细描述
Study Objectives
Primary Objective:
To compare the outcomes of RAPN performed with the SARA approach versus the standard flank approach in achieving a "trifecta outcome," defined as:
- No intraoperative adverse events;
- Negative (cancer-free) surgical margins;
- Hospital discharge on postoperative day 1.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age ≥ 18 years;
- •Presence of a single, unilateral, primary renal mass ≤ 7 cm in diameter (clinical stage cT1) documented CT scan
- •No evidence of systemic disease or lymph node involvement;
- •Candidate for robot-assisted partial nephrectomy using the Da Vinci SP platform;
- •Signed informed consent
- •Absence of solitary kidney status
- •No previous partial nephrectomy/ies on the same kidney
- •Absence of preoperative chronic kidney disease (CKD) stage 5
- •Absence of any condition that makes mandatory or significantly more adequate the choice of a specific approach over the others (e.g., multiple previous major abdominal surgeries, horseshoe kidney, presence of stomas)
排除标准
- 未提供
研究组 & 干预措施
GROUP A - STANDARD FLANK APPROACH
Patients are positioned laterally (on their side) with the operative flank elevated at a 12-15° angle. The Da Vinci SP robotic system is docked either transperitoneally or retroperitoneally through a single access port.
干预措施: STANDARD FLANK APPROACH (Other)
GROUP B - Supine anterior retroperitoneal approach (SARA).
Patients are positioned supine with a mild Trendelenburg tilt (0°-10°). A retroperitoneal space is created through an anterior incision, providing direct access to the kidney without repositioning.
干预措施: Supine anterior retroperitoneal approach (SARA). (Procedure)
结局指标
主要结局
TRIFECTA
时间窗: Intra and perioperative
Trifecta is defined as the coexistence of these three conditions: 1. Absence of any intraoperative adverse event 2. Absence of positive surgical margins 3. Hospital discharge at postoperative day 1
次要结局
- 30 day complications(30 postoperative days)
- Partial trifecta achievement(Intra and perioperative)