Comparing robot-assisted kidney surgery in different positions

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

This study is testing if having kidney surgery with a robot while lying face down is better for recovery and results compared to the usual side position for patients with kidney tumors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06572501 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and feasibility of robot-assisted laparoscopic partial nephrectomy using an extraperitoneal approach in the prone position compared to the traditional lateral position. Participants will be randomly assigned to one of the two groups to assess any advantages of the prone position regarding surgical outcomes and patient prognosis. The study aims to determine if the position during surgery impacts recovery and overall results for patients with renal tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with imaging suggestive of renal tumors who are suitable for robotic-assisted laparoscopic partial nephrectomy.

Not a fit: Patients who cannot tolerate surgery in either the prone or lateral position or do not meet the criteria for partial nephrectomy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing kidney surgery.

How similar studies have performed: While the approach of using the prone position for robotic surgery is being explored, this specific comparison has not been widely tested, making it a novel investigation.

Eligibility criteria

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;

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Qiang Lu

Conditions: Renal Tumor, Prone Position, Robotic Assisted Partial Nephrectomy