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

August 26, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumour characteristics checklist
Time Frame: Baseline ( before surgery)
We will record tumor size (cm), location, position, laterality through preoperative imaging.
Baseline ( before surgery)
Tumour characteristics assessed by RENAL nephrometry score
Time Frame: 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.
Baseline ( before surgery)
Demographics of patients
Time Frame: Baseline ( before surgery)
age (year)
Baseline ( before surgery)
Demographics of patients
Time Frame: Baseline ( before surgery)
gender
Baseline ( before surgery)
Demographics of patients
Time Frame: Baseline ( before surgery)
BMI (kg/m2)
Baseline ( before surgery)
Demographics of patients
Time Frame: Baseline ( before surgery)
American Society of Anesthesiology score
Baseline ( before surgery)
Demographics of patients
Time Frame: Baseline ( before surgery)
age-adjusted charlson comorbidity index
Baseline ( before surgery)
Demographics of patients
Time Frame: Baseline ( before surgery)
preoperative estimated glomerular filtration rate(ml/min/1.73m2).
Baseline ( before surgery)
Perioperative data
Time Frame: Intraoperative status
intraoperative average PaCO2(mmHg).
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
operation time(minute)
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
hilar access time(minute)
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
warm ischemia time(minute).
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
suturing time(minute).
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
estimated blood loss(ml).
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
transfusion rate(%)
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
rate of positive surgical margin(%)
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
conversion rates to open surgery(%)
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
conversion rates to radical nephrectomy(%)
Intraoperative status
Perioperative data
Time Frame: Intraoperative status
reoperation rate(%)
Intraoperative status
Perioperative data
Time Frame: Postoperative 30 days
postoperative length of stay (day).
Postoperative 30 days
postoperative data
Time Frame: Postoperative 3/30/60/90 days and 1/2/3 years
postoperative estimated glomerular filtration rate(ml/min/1.73m2).
Postoperative 3/30/60/90 days and 1/2/3 years
Incidence of postoperative complications
Time Frame: 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.
Postoperative 3/30/60/90 days and 1/2/3 years
Tumour recurrence or metastasis
Time Frame: 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.
Postoperative 30/60/90 days and 1/2/3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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