Urinary CalculiNCT05574517
Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter
A study testing Without reverse insertion of a ureteral catheter in people with Urinary Calculi and Percutaneous Nephrolithotomy, run by The First Affiliated Hospital of University of South China at 1 site in China.
Trial summary
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Calculi, Percutaneous Nephrolithotomy
- What is being tested?
- Without reverse insertion of a ureteral catheter
- 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
- 7 Oct 2022to 31 Dec 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases
- Participants who agree to undergo tubeless PCNL
- The participants' maximum diameter of the stone should be less than 3.5cm
Who cannot join
- Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
- Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
- Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
- Renal trauma or congenital malformation of the urinary system
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Mingyong LI, 18175878363, myli1123@126.com
About this study
Official title: A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.
Read the detailed description
This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. The doctors managing the operations accept participants and execute the surgical treatments. All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation. Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.
- Conditions
- Urinary Calculi, Percutaneous Nephrolithotomy
- Being tested
- Without reverse insertion of a ureteral catheter
- Keywords
- Ureteral catheter, Without reverse insertion, Percutaneous nephrolithotomy, Tubeless, Urinary calculi
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without reverse insertion of a ureteral catheterProcedure or surgery
Traditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group(group 1) | Experimental | Without reverse insertion of a ureteral catheter in tubeless percutaneous nephrolithotomy. Receives: Procedure: Without reverse insertion of a ureteral catheter |
| Control group(group 2) | No intervention | Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of inflammatory indicators after surgery
Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference
Measured: Hour 3 after the surgery
Changes in renal bleeding after surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
Measured: Hour 3 after the surgery
Changes of renal-function after surgery
Preoperative and postoperative blood creatinine difference
Measured: Hour 3 after the surgery
Pain score after surgery
According to the Visual Analogue Scale(VAS) to evaluate the score. Scores range from 0 to 10, where 0 represents no pain and 10 represents the highest pain.
Measured: Hour 3 after the surgery
Incidence of pneumothorax and hydrothorax
The rate of pneumothorax and hydrothorax after surgery
Measured: Day 2 after the surgery
Incidence of ureteral stone street
The rate of ureteral stone street after surgery
Measured: Day 2 after the surgery
Secondary outcomes (4)
Duration of operation
From the completion of anesthesia to the end of the suture incision.
Measured: during the procedure
Duration of hospital stay
From the date of admission to the date of discharge.
Measured: immediately after the discharge
Hospital costs
The cost from hospitalization to discharge.
Measured: immediately after the discharge
Stone-free rates
Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi < 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%).
Measured: Day 2 after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start7 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies 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
- Model description
- Participants are randomly assigned to an experimental or control group in parallel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of South China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Mingyong, MD, The First Affiliated Hospital of University of South China
- Investigators
- Mingyong Li, MD, Principal investigator, The First Affiliated Hospital of University of South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574517
- Sponsor's protocol ID
- USCKF201902K01
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2022
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion
- ClinicalTrials.gov ID
- NCT05574517
- Acronym / sponsor ID
- USCKF201902K01
- Conditions
- Urinary Calculi, Percutaneous Nephrolithotomy
- Keywords
- Ureteral catheter, Without reverse insertion, Percutaneous nephrolithotomy, Tubeless, Urinary calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of South ChinaUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2022 (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.
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.
Detailed description
This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. The doctors managing the operations accept participants and execute the surgical treatments. All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation. Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to an experimental or control group in parallel.
| Arm | Type | Receives |
|---|---|---|
| Experimental group(group 1) | Experimental | Procedure: Without reverse insertion of a ureteral catheterWithout reverse insertion of a ureteral catheter in tubeless percutaneous nephrolithotomy. |
| Control group(group 2) | No intervention | –Traditional tubeless percutaneous nephrolithotomy need reverse insert a ureteral catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases
- Participants who agree to undergo tubeless PCNL
- The participants' maximum diameter of the stone should be less than 3.5cm
Key exclusion criteria (4 listed)
- Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
- Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
- Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
- Renal trauma or congenital malformation of the urinary system
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 |
|---|---|---|
| Without reverse insertion of a ureteral catheterTraditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter. | Procedure or surgery | Experimental group(group 1) |
Primary outcome
Changes of inflammatory indicators after surgery
Time frame: Hour 3 after the surgery
Pre- vs. post-operative blood leukocyte counts and neutrophil-ratio difference
Changes in renal bleeding after surgery
Time frame: Hour 3 after the surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
Changes of renal-function after surgery
Time frame: Hour 3 after the surgery
Preoperative and postoperative blood creatinine difference
Pain score after surgery
Time frame: Hour 3 after the surgery
According to the Visual Analogue Scale(VAS) to evaluate the score. Scores range from 0 to 10, where 0 represents no pain and 10 represents the highest pain.
Incidence of pneumothorax and hydrothorax
Time frame: Day 2 after the surgery
The rate of pneumothorax and hydrothorax after surgery
Incidence of ureteral stone street
Time frame: Day 2 after the surgery
The rate of ureteral stone street after surgery
4 secondary outcomes
Duration of operation
Time frame: during the procedure
Duration of hospital stay
Time frame: immediately after the discharge
Hospital costs
Time frame: immediately after the discharge
Stone-free rates
Time frame: Day 2 after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication.
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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. This study is not recruiting at the moment.
Mingyong Li, MD principal investigator
The First Affiliated Hospital of University of South China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without reverse insertion of a ureteral catheter in people with Urinary Calculi and Percutaneous Nephrolithotomy, run by The First Affiliated Hospital of University of South China 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 3 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 24 Sep 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 Mingyong Li, MD (18175878363, myli1123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of inflammatory indicators after surgery (time frame: Hour 3 after the surgery). 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 24 Sep 2024.