Renal TumorNCT06572501
Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position
A study testing Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position and Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position in people with Renal Tumor and Prone Position, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumor, Prone Position, Robotic Assisted Partial Nephrectomy
- What is being tested?
- Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position and Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2023to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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.
Who cannot join
- . Patients who did not meet the indications for partial nephrectomy and did not undergo robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach;
- . Patients who refuse to undergo or cannot tolerate surgery in the appropriate position;
- . Patients with incomplete documentation of relevant data to provide accurate demographic, perioperative, and prognostic data;
- . 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;
- . Patients who are unable to provide written informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: 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.
- Being tested
- Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position, Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone positionProcedure or surgery
This group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position
Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral positionProcedure or surgery
This group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position
| Study group | Role | What they receive |
|---|---|---|
| Prone position | Experimental | Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position Receives: Procedure: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position |
| Lateral position | Active comparator | Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position Receives: Procedure: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour characteristics checklist
We will record tumor size (cm), location, position, laterality through preoperative imaging.
Measured: 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.
Measured: Baseline ( before surgery)
Demographics of patients
age (year)
Measured: Baseline ( before surgery)
Demographics of patients
gender
Measured: Baseline ( before surgery)
Demographics of patients
BMI (kg/m2)
Measured: Baseline ( before surgery)
Demographics of patients
American Society of Anesthesiology score
Measured: Baseline ( before surgery)
Demographics of patients
age-adjusted charlson comorbidity index
Measured: Baseline ( before surgery)
Demographics of patients
preoperative estimated glomerular filtration rate(ml/min/1.73m2).
Measured: Baseline ( before surgery)
Perioperative data
intraoperative average PaCO2(mmHg).
Measured: Intraoperative status
Perioperative data
operation time(minute)
Measured: Intraoperative status
Perioperative data
hilar access time(minute)
Measured: Intraoperative status
Perioperative data
warm ischemia time(minute).
Measured: Intraoperative status
Perioperative data
suturing time(minute).
Measured: Intraoperative status
Perioperative data
estimated blood loss(ml).
Measured: Intraoperative status
Perioperative data
transfusion rate(%)
Measured: Intraoperative status
Perioperative data
rate of positive surgical margin(%)
Measured: Intraoperative status
Perioperative data
conversion rates to open surgery(%)
Measured: Intraoperative status
Perioperative data
conversion rates to radical nephrectomy(%)
Measured: Intraoperative status
Perioperative data
reoperation rate(%)
Measured: Intraoperative status
Perioperative data
postoperative length of stay (day).
Measured: Postoperative 30 days
postoperative data
postoperative estimated glomerular filtration rate(ml/min/1.73m2).
Measured: 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.
Measured: 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.
Measured: Postoperative 30/60/90 days and 1/2/3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start6 Aug 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572501
- Sponsor's protocol ID
- 2023-SR-614.A1
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06572501
- Acronym / sponsor ID
- 2023-SR-614.A1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position | Experimental | Procedure: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone positionRobot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position |
| Lateral position | Active comparator | Procedure: Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral positionRobot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- . 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;
Key exclusion criteria (5 listed)
- . Patients who did not meet the indications for partial nephrectomy and did not undergo robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach;
- . Patients who refuse to undergo or cannot tolerate surgery in the appropriate position;
- . Patients with incomplete documentation of relevant data to provide accurate demographic, perioperative, and prognostic data;
- . 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;
- . Patients who are unable to provide written informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone positionThis group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position | Procedure or surgery | Prone position |
| Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral positionThis group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position | Procedure or surgery | Lateral position |
Primary outcome
Tumour characteristics checklist
Time frame: Baseline ( before surgery)
We will record tumor size (cm), location, position, laterality through preoperative imaging.
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.
Demographics of patients
Time frame: Baseline ( before surgery)
age (year)
Demographics of patients
Time frame: Baseline ( before surgery)
gender
Demographics of patients
Time frame: Baseline ( before surgery)
BMI (kg/m2)
Demographics of patients
Time frame: Baseline ( before surgery)
American Society of Anesthesiology score
Demographics of patients
Time frame: Baseline ( before surgery)
age-adjusted charlson comorbidity index
Demographics of patients
Time frame: Baseline ( before surgery)
preoperative estimated glomerular filtration rate(ml/min/1.73m2).
Perioperative data
Time frame: Intraoperative status
intraoperative average PaCO2(mmHg).
Perioperative data
Time frame: Intraoperative status
operation time(minute)
Perioperative data
Time frame: Intraoperative status
hilar access time(minute)
Perioperative data
Time frame: Intraoperative status
warm ischemia time(minute).
Perioperative data
Time frame: Intraoperative status
suturing time(minute).
Perioperative data
Time frame: Intraoperative status
estimated blood loss(ml).
Perioperative data
Time frame: Intraoperative status
transfusion rate(%)
Perioperative data
Time frame: Intraoperative status
rate of positive surgical margin(%)
Perioperative data
Time frame: Intraoperative status
conversion rates to open surgery(%)
Perioperative data
Time frame: Intraoperative status
conversion rates to radical nephrectomy(%)
Perioperative data
Time frame: Intraoperative status
reoperation rate(%)
Perioperative data
Time frame: Postoperative 30 days
postoperative length of stay (day).
postoperative data
Time frame: Postoperative 3/30/60/90 days and 1/2/3 years
postoperative estimated glomerular filtration rate(ml/min/1.73m2).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position and Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position in people with Renal Tumor and Prone Position, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Lu (13505196501, doctorlvqiang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour characteristics checklist (time frame: Baseline ( before surgery)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.