Nephrolithotomy PercutaneousNCT05598671
Percutaneous Nephrolithotomy Without a Ureteral Catheter
A study testing PCNL without reverse insertion of a ureteral catheter in people with Nephrolithotomy Percutaneous and Kidney Calculi, run by The First Affiliated Hospital of University of South China at 1 site in China.
Trial summary
Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrolithotomy Percutaneous, Kidney Calculi
- What is being tested?
- PCNL 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
- 3 Nov 2022to 1 Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.
Who cannot join
- patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes.
- Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications.
- Patients with previous history of PCNL surgery on the affected side or nephrotomy.
- Patients with indwelling double J tube or nephrostomy tube before operation.
- Patients with renal trauma or congenital anomalies of 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, MD., 18175878363 ext. +86, myli1123@126.com
About this study
Official title: A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy
Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.
Read the detailed description
The purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of PCNL without reverse insertion of a ureteral catheter. It is planned to start in November 2022 and is expected to end in November 2024. Based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received PCNL without reverse insertion of a ureteral catheter , and the control group received traditional PCNL. The primary end point of the study was the incidence of postoperative complications according to the modified Clavien-Dindo complication grading system. Secondary end points included Stone-free rate, operation time, length of hospital stay, and medical costs. Measurement data were expressed as mean ± standard deviation (X ± S), and Student's t-test was used for intergroup comparisons. The counting data were expressed as frequency and percentage, and the chi-squared or Fisher's exact probability test were used for intergroup comparisons. The rank-sum test was used for grade data. P<0.05 was considered statistically significant.
- Conditions
- Nephrolithotomy Percutaneous, Kidney Calculi
- Being tested
- PCNL without reverse insertion of a ureteral catheter
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNL without reverse insertion of a ureteral catheterProcedure or surgery
The ureteral catheter was not retrograde inserted during PCNL
| Study group | Role | What they receive |
|---|---|---|
| without reverse insertion of a ureteral catheter | Experimental | Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter Receives: Procedure: PCNL without reverse insertion of a ureteral catheter |
| Conventional | No intervention | Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fever
Fever was defined as axillary temperature greater than 38.5 ° C.
Measured: From the day of surgery to the day of discharge, up to 2 weeks.
White blood cell count change value
The change value of White blood cell count between preoperative and postoperative
Measured: Day 2 before surgery、hour 3 after the surgery
Neutrophils granulocyte change value
The change value of Neutrophils granulocyte between preoperative and postoperative
Measured: Day 2 before surgery、hour 3 after the surgery
Hemoglobin change value
The change value of Hemoglobin between preoperative and postoperative
Measured: Day 2 before surgery、hour 3 after the surgery
Hematocrit change value
The change value of Hematocrit between preoperative and postoperative
Measured: Day 2 before surgery、hour 3 after the surgery
Rate of renal subcapsular hematoma
The proportion of postoperative renal subcapsular hematoma in all patients
Measured: Day 2 after the surgery
Serum creatinine change value
The change value of Serum creatinine between preoperative and postoperative
Measured: Day 2 before surgery、Hour 3 after the surgery
visual analog scale (VAS)pain score
0: no pain; Less than 3 points: mild pain, tolerable; 4 points to 6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep.
Measured: Hour 2 after the surgery
Rate of hydrothorax
Hydrothorax appeared on the surgical side.
Measured: Day 2 after the surgery
Secondary outcomes (4)
Stone free rate
Residual stone less than 4mm in diameter was considered to have been cleared.
Measured: Day 2 after the surgery
Operation time
Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture
Measured: During the procedure
length of hospital stay
Length of hospital stay indicated the number of days between the operation date and discharge date
Measured: 2 weeks after surgery
Medical costs
All medical expenses incurred to treat stones.
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start3 Nov 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrolithotomy PercutaneousStudies 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
- 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., Study director, the First Affiliated Hospital of the University of South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598671
- Sponsor's protocol ID
- nhfy0520
- Status last verified
- Feb 2024
- First submitted
- 25 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available to other researchers after the study Report are published.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05598671
- Acronym / sponsor ID
- nhfy0520
- Conditions
- Nephrolithotomy Percutaneous, Kidney 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
- 3 Nov 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 28 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.
Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.
Detailed description
The purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of PCNL without reverse insertion of a ureteral catheter. It is planned to start in November 2022 and is expected to end in November 2024. Based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received PCNL without reverse insertion of a ureteral catheter , and the control group received traditional PCNL. The primary end point of the study was the incidence of postoperative complications according to the modified Clavien-Dindo complication grading system. Secondary end points included Stone-free rate, operation time, length of hospital stay, and medical costs. Measurement data were expressed as mean ± standard deviation (X ± S), and Student's t-test was used for intergroup comparisons. The counting data were expressed as frequency and percentage, and the chi-squared or Fisher's exact probability test were used for intergroup comparisons. The rank-sum test was used for grade data. P<0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without reverse insertion of a ureteral catheter | Experimental | Procedure: PCNL without reverse insertion of a ureteral catheterPercutaneous nephrolithotomy without reverse insertion of a ureteral catheter |
| Conventional | No intervention | –Percutaneous nephrolithotomy with reverse insertion of 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 (1 listed)
- Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.
Key exclusion criteria (5 listed)
- patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes.
- Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications.
- Patients with previous history of PCNL surgery on the affected side or nephrotomy.
- Patients with indwelling double J tube or nephrostomy tube before operation.
- Patients with renal trauma or congenital anomalies of 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 |
|---|---|---|
| PCNL without reverse insertion of a ureteral catheterThe ureteral catheter was not retrograde inserted during PCNL | Procedure or surgery | without reverse insertion of a ureteral catheter |
Primary outcome
Rate of fever
Time frame: From the day of surgery to the day of discharge, up to 2 weeks.
Fever was defined as axillary temperature greater than 38.5 ° C.
White blood cell count change value
Time frame: Day 2 before surgery、hour 3 after the surgery
The change value of White blood cell count between preoperative and postoperative
Neutrophils granulocyte change value
Time frame: Day 2 before surgery、hour 3 after the surgery
The change value of Neutrophils granulocyte between preoperative and postoperative
Hemoglobin change value
Time frame: Day 2 before surgery、hour 3 after the surgery
The change value of Hemoglobin between preoperative and postoperative
Hematocrit change value
Time frame: Day 2 before surgery、hour 3 after the surgery
The change value of Hematocrit between preoperative and postoperative
Rate of renal subcapsular hematoma
Time frame: Day 2 after the surgery
The proportion of postoperative renal subcapsular hematoma in all patients
Serum creatinine change value
Time frame: Day 2 before surgery、Hour 3 after the surgery
The change value of Serum creatinine between preoperative and postoperative
visual analog scale (VAS)pain score
Time frame: Hour 2 after the surgery
0: no pain; Less than 3 points: mild pain, tolerable; 4 points to 6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep.
Rate of hydrothorax
Time frame: Day 2 after the surgery
Hydrothorax appeared on the surgical side.
4 secondary outcomes
Stone free rate
Time frame: Day 2 after the surgery
Operation time
Time frame: During the procedure
length of hospital stay
Time frame: 2 weeks after surgery
Medical costs
Time frame: 2 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available to other researchers after the study Report are published.
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Safety, Efficacy
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. study director
the First Affiliated Hospital of the 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 PCNL without reverse insertion of a ureteral catheter in people with Nephrolithotomy Percutaneous and Kidney Calculi, 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 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 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. (137-8648-4606 ext. +86, myli1123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fever (time frame: From the day of surgery to the day of discharge, up to 2 weeks.). The study lists 9 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 28 Feb 2024.