Nonfunctional KidneyNCT06565598
Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
A study testing Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy in people with Nonfunctional Kidney and Renal Cancer, run by The First People's Hospital of Xiushui at 1 site in China.
Trial summary
To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nonfunctional Kidney, Renal Cancer
- What is being tested?
- Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with various causes requiring radical nephrectomy
Who cannot join
- patients who could not tolerate laparoscopic surgery for various reasons
- patients whose preoperative blood pressure and blood glucose were not controlled to normal
- patients with contralateral nonfunctioning kidney or solitary kidney
- Multiple organ surgery at the same time
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First People 's Hospital of Xiushui
Jiujiang
Baisheng Xu, Ph.D, +8618779248191, 416915611@qq.com
About this study
Official title: Observation on the Efficacy of Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization
Read the detailed description
In this study, a multi-center retrospective study was conducted to evaluate the clinical efficacy of single-layer robot-assisted peritoneal retroperitoneal radical nephrectomy in patients with nephrectomy, and to compare the safety and effectiveness of traditional robot-assisted peritoneal radical nephrectomy
- Conditions
- Nonfunctional Kidney, Renal Cancer
- Being tested
- Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy
- Keywords
- Laparoscopic radical nephrectomy, Transperitoneal approach, Robotic surgery, Tubeless
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomyProcedure or surgery
Also called Single layer approach
Free through the single layer of the posterior abdominal cavity
| Study group | Role | What they receive |
|---|---|---|
| Traditional robot-assisted transabdominal radical nephrectomy | No intervention | Radical nephrectomy was performed through traditional robot-assisted transabdominal approach |
| Traditional laparoscopic transabdominal radical nephrectomy | No intervention | Traditional laparoscopic radical nephrectomy was performed |
| Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy | Experimental | Through a single-level surgical approach, surgical robot-assisted transperitoneal retroperitoneal radical nephrectomy was performed. Receives: Procedure: Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
Blood loss during operation
Measured: 24 months
postoperative time of getting out of bed
Time to get out of bed after surgery
Measured: 24 months
postoperative hospital stay
Length of hospital stay after surgery
Measured: 2-5 Days
Whether to convert to laparotomy or not
According to the surgical records in the medical records, whether the operation was converted to laparotomy was checked, and the data were recorded when collecting the data.
Measured: 24 months
Operation time
Complete operative time
Measured: 1-3 Hours
whether the tumor was completely removed
Observe whether the tumor is complete according to the naked eye after surgery，Record and record to the surgical record, record when collecting the receipt.
Measured: 24 months
Secondary outcomes (1)
Clavien-Dindo grading
Grade I : long-term pain, fever, continuous bleeding and exudate, transient intestinal obstruction ; grade II : need blood transfusion, pneumonia ; grade III : hematuria requiring cystoscopy ; level IV : renal insufficiency requiring hemodialysis, respiratory insufficiency requiring ICU treatment, and cardiac insufficiency requiring ICU care.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 May 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonfunctional KidneyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Xiushui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565598
- Sponsor's protocol ID
- GSL2024005
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 22 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Efficacy of Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy
- ClinicalTrials.gov ID
- NCT06565598
- Acronym / sponsor ID
- GSL2024005
- Conditions
- Nonfunctional Kidney, Renal Cancer
- Keywords
- Laparoscopic radical nephrectomy, Transperitoneal approach, Robotic surgery, Tubeless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First People's Hospital of XiushuiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 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.
To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization
Detailed description
In this study, a multi-center retrospective study was conducted to evaluate the clinical efficacy of single-layer robot-assisted peritoneal retroperitoneal radical nephrectomy in patients with nephrectomy, and to compare the safety and effectiveness of traditional robot-assisted peritoneal radical nephrectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional robot-assisted transabdominal radical nephrectomy | No intervention | –Radical nephrectomy was performed through traditional robot-assisted transabdominal approach |
| Traditional laparoscopic transabdominal radical nephrectomy | No intervention | –Traditional laparoscopic radical nephrectomy was performed |
| Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy | Experimental | Procedure: Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomyThrough a single-level surgical approach, surgical robot-assisted transperitoneal retroperitoneal radical nephrectomy was performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with various causes requiring radical nephrectomy
Key exclusion criteria (4 listed)
- patients who could not tolerate laparoscopic surgery for various reasons
- patients whose preoperative blood pressure and blood glucose were not controlled to normal
- patients with contralateral nonfunctioning kidney or solitary kidney
- Multiple organ surgery at the same time
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 |
|---|---|---|
| Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomyAlso: Single layer approachFree through the single layer of the posterior abdominal cavity | Procedure or surgery | Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy |
Primary outcome
intraoperative blood loss
Time frame: 24 months
Blood loss during operation
postoperative time of getting out of bed
Time frame: 24 months
Time to get out of bed after surgery
postoperative hospital stay
Time frame: 2-5 Days
Length of hospital stay after surgery
Whether to convert to laparotomy or not
Time frame: 24 months
According to the surgical records in the medical records, whether the operation was converted to laparotomy was checked, and the data were recorded when collecting the data.
Operation time
Time frame: 1-3 Hours
Complete operative time
whether the tumor was completely removed
Time frame: 24 months
Observe whether the tumor is complete according to the naked eye after surgery，Record and record to the surgical record, record when collecting the receipt.
1 secondary outcome
Clavien-Dindo grading
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy in people with Nonfunctional Kidney and Renal Cancer, run by The First People's Hospital of Xiushui 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baisheng Xu, Ph.D (+86-18779248191, 416915611@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss (time frame: 24 months). The study lists 6 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 22 Aug 2024.