Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position

Condition(s) studied

Investigational drug(s) / intervention(s)

Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position: This group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position

Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position: This group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position

Study 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\' 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More The First Affiliated Hospital with Nanjing Medical University trials in China

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