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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Tumor; Prone Position; Robotic Assisted Partial Nephrectomy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiang Lu; Phone Number: 13505196501; Email: doctorlvqiang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. . Patients with preoperative imaging suggestive of renal occupancy;
2. . Sex is not limited;
3. . Age ≥18 years;
4. . Clinical staging consistent with indications for partial nephrectomy;
5. . Suitable for robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach as judged by relevant preoperative clinical data;
6. . Agree to provide basic clinical information and pathological and imaging data for scientific research and sign an informed consent form;
7. . Agree to provide monitoring results during the follow-up recurrence monitoring process.

Exclusion Criteria:

1. . Patients who did not meet the indications for partial nephrectomy and did not undergo robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach;
2. . Patients who refuse to undergo or cannot tolerate surgery in the appropriate position;
3. . Patients with incomplete documentation of relevant data to provide accurate demographic, perioperative, and prognostic data;
4. . 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;
5. . Patients who are unable to provide written informed consent;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prone position; Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position	Procedure: 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
Active Comparator: Lateral position; Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: August 4, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: 2023-SR-614.A1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No