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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• . 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.

Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Qiang Lu
doctorlvqiang@njmu.edu.cn
13505196501
Time Frame
Start Date: 2023-08-06
Estimated Completion Date: 2030-01
Participants
Target number of participants: 200
Treatments
Experimental: Prone position
Robot-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
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov