Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral position-a Study Protocol for a Single-centre, Prospective, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tumour recurrence or metastasis
研究概览
简要总结
The goal of this clinical trial is to investigate whether robot-assisted laparoscopic partial nephrectomy by extraperitoneal approach in the prone position had any advantages over the traditional lateral position. The main questions it aims to answer are:
Is prone surgery safe and feasible, and what are the advantages over the traditional lateral position? Does surgery in the prone position have an impact on the patients' prognosis? Researchers will compare prone position to lateral position to see if robot-assisted laparoscopic partial nephrectomy by extraperitoneal approach in the prone position has any advantages over the traditional lateral position and whether it has any significant effect on the prognosis of the patients.
Participants will be randomly allocated 1:1 to two groups: prone position group and lateral position group. The enrolled patients will be underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach according to the corresponding positions of their groups. Demographic indicators and perioperative-related indicators will be counted and recorded. CT or MRI and related biochemical examinations will be reviewed at 1 month, 3 months, 6 months and 1 year after surgery, and every 1 year thereafter. The similarities and differences of the indicators in different positions will be analysed, and subgroup analyses will be performed according to the corresponding results.
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 with preoperative imaging suggestive of renal occupancy;
- •. Sex is not limited;
- •. Age ≥18 years;
- •. Clinical staging consistent with indications for partial nephrectomy;
- •. Suitable for robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach as judged by relevant preoperative clinical data;
- •. Agree to provide basic clinical information and pathological and imaging data for scientific research and sign an informed consent form;
- •. Agree to provide monitoring results during the follow-up recurrence monitoring process.
排除标准
- •. Patients who did not meet the indications for partial nephrectomy and did not undergo robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach;
- •. Patients who refuse to undergo or cannot tolerate surgery in the appropriate position;
- •. Patients with incomplete documentation of relevant data to provide accurate demographic, perioperative, and prognostic data;
- •. Any condition which, in the opinion of the investigator, may be detrimental to the subject or result in the inability of the subject to meet or perform the requirements of the study;
- •. Patients who are unable to provide written informed consent;
研究组 & 干预措施
Prone position
Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position
干预措施: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position (Procedure)
Lateral position
Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position
干预措施: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position (Procedure)
结局指标
主要结局
Tumour recurrence or metastasis
时间窗: Postoperative 30/60/90 days and 1/2/3 years
We will conduct telephone follow-up and review the results of postoperative radiological tests to see whether tumour recurrence or metastasis occurred.
Incidence of postoperative complications
时间窗: Postoperative 3/30/60/90 days and 1/2/3 years
We will assess the complications by conducting telephone follow-up, as well as reviewing the results of postoperative radiological and laboratory tests. The complications included whether the patients experienced bleeding, infection, urinary fistula and renal insufficiency.
Demographics of patients
时间窗: Baseline ( before surgery)
age (year)
Tumour characteristics checklist
时间窗: Baseline ( before surgery)
We will record tumor size (cm), location, position, laterality through preoperative imaging.
postoperative data
时间窗: Postoperative 3/30/60/90 days and 1/2/3 years
postoperative estimated glomerular filtration rate(ml/min/1.73m2).
Tumour characteristics assessed by RENAL nephrometry score
时间窗: Baseline ( before surgery)
The R.E.N.A.L. Nephrometry Score consists of (R)adius (tumor size as maximal diameter), (E)xophytic/endophytic properties of the tumor, (N)earness of tumor deepest portion to the collecting system or sinus, (A)nterior (a)/posterior (p) descriptor and the (L)ocation relative to the polar line. The suffix h (hilar) is assigned to tumors that abut the main renal artery or vein. Of the 5 components 4 are scored on a 1, 2 or 3-point scale with the 5th indicating the anterior or posterior location of the mass relative to the coronal plane of the kidney. Higher scores indicate more complex tumour.
Perioperative data
时间窗: Postoperative 30 days
postoperative length of stay (day).
Perioperative data
时间窗: Intraoperative status
intraoperative average PaCO2(mmHg).
次要结局
未报告次要终点