Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position
NCT Number: NCT06572501
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Renal Tumor|Prone Position|Robotic Assisted Partial Nephrectomy
Interventions: PROCEDURE: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position|PROCEDURE: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-06
Completion Date: 2030-01
Locations: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Summary:
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\&#39; 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.

Primary Outcome Measures: Tumour characteristics checklist, We will record tumor size (cm), location, position, laterality through preoperative imaging., Baseline ( before surgery)|Tumour characteristics assessed by RENAL nephrometry score, 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., Baseline ( before surgery)|Demographics of patients, age (year), Baseline ( before surgery)|Demographics of patients, gender, Baseline ( before surgery)|Demographics of patients, BMI (kg/m2), Baseline ( before surgery)|Demographics of patients, American Society of Anesthesiology score, Baseline ( before surgery)|Demographics of patients, age-adjusted charlson comorbidity index, Baseline ( before surgery)|Demographics of patients, preoperative estimated glomerular filtration rate(ml/min/1.73m2)., Baseline ( before surgery)|Perioperative data, intraoperative average PaCO2(mmHg)., Intraoperative status|Perioperative data, operation time(minute), Intraoperative status|Perioperative data, hilar access time(minute), Intraoperative status|Perioperative data, warm ischemia time(minute)., Intraoperative status|Perioperative data, suturing time(minute)., Intraoperative status|Perioperative data, estimated blood loss(ml)., Intraoperative status|Perioperative data, transfusion rate(%), Intraoperative status|Perioperative data, rate of positive surgical margin(%), Intraoperative status|Perioperative data, conversion rates to open surgery(%), Intraoperative status|Perioperative data, conversion rates to radical nephrectomy(%), Intraoperative status|Perioperative data, reoperation rate(%), Intraoperative status|Perioperative data, postoperative length of stay (day)., Postoperative 30 days|postoperative data, postoperative estimated glomerular filtration rate(ml/min/1.73m2)., Postoperative 3/30/60/90 days and 1/2/3 years|Incidence of postoperative complications, 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., Postoperative 3/30/60/90 days and 1/2/3 years|Tumour recurrence or metastasis, We will conduct telephone follow-up and review the results of postoperative radiological tests to see whether tumour recurrence or metastasis occurred., Postoperative 30/60/90 days and 1/2/3 years