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

Not Applicable

Recruiting

• Conditions: Robotic Assisted Partial Nephrectomy; Renal Tumor; Prone Position
• Interventions: Procedure: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position; Procedure: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position

• Registration Number: NCT06572501
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-06
• Status Verified: 2024-08
• Study First Submitted: 2024-08-04
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2027-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral position	Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position	Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position
Prone position	Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position	Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position

Primary Outcome Measures

Name	Time	Method
Tumour characteristics checklist	Baseline ( before surgery)	We will record tumor size (cm), location, position, laterality through preoperative imaging.
Perioperative data	Postoperative 30 days	postoperative length of stay (day).
Demographics of patients	Baseline ( before surgery)	preoperative estimated glomerular filtration rate(ml/min/1.73m2).
postoperative data	Postoperative 3/30/60/90 days and 1/2/3 years	postoperative estimated glomerular filtration rate(ml/min/1.73m2).
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.
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.
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China