Nephrolithotomy, PercutaneousNCT05578807
Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter
A study testing without reverse ureteral catheter insertion 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
Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. 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?
- without reverse ureteral catheter insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2022to 10 Jan 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 kidney stones who met the indications for PCNL surgery.
- the maximum diameter of calculi was less than 35 mm.
- the width of hydronephrosis effusion was less than 25mm.
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, 18175878363 ext. +86, myli1123@126.com
About this study
Official title: A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless Percutaneous Nephrolithotomy
Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.
Read the detailed description
The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless 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
- without reverse ureteral catheter insertion
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without reverse ureteral catheter insertionProcedure or surgery
In contrast to conventional total tubeless percutaneous nephrolithotomy, there was no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no change in position, and no repeated disinfection.
| Study group | Role | What they receive |
|---|---|---|
| Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter | Experimental | In total tubeless percutaneous nephrolithotomy surgery, there is no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no need to change the position, and no need to re-sterilize and lay towels. Receives: Procedure: without reverse ureteral catheter insertion |
| Conventional total tubeless percutaneous nephrolithotomy | No intervention | In total tubeless percutaneous nephrolithotomy surgery, there is reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, need to change the position, and need to re-sterilize and lay towels. |
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
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 posted13 Oct 2022
- Study start28 Sep 2022
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Jan 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
- 100 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
- NCT05578807
- Sponsor's protocol ID
- 2020SK51801
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2022
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. 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 Total Tubeless Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05578807
- Acronym / sponsor ID
- 2020SK51801
- Conditions
- Nephrolithotomy, Percutaneous, Kidney Calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of South ChinaUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 13 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.
Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular PCNL surgery.
Detailed description
The purpose of this single-center, single-blind, randomized trial was to investigate whether without retrograde insertion of a ureteral catheter is appropriate for total tubeless percutaneous nephrolithotomy. It is planned to start in October 2022 and is expected to end in October 2024. Based on inclusion and exclusion criteria, 100 subjects were expected to be recruited. In a parallel group design, subjects were randomly assigned to two groups: the experimental group received total tubeless PCNL without reverse insertion of a ureteral catheter , and the control group received conventional total tubeless 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 |
|---|---|---|
| Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter | Experimental | Procedure: without reverse ureteral catheter insertionIn total tubeless percutaneous nephrolithotomy surgery, there is no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no need to change the position, and no need to re-sterilize and lay towels. |
| Conventional total tubeless percutaneous nephrolithotomy | No intervention | –In total tubeless percutaneous nephrolithotomy surgery, there is reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, need to change the position, and need to re-sterilize and lay towels. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with kidney stones who met the indications for PCNL surgery.
- the maximum diameter of calculi was less than 35 mm.
- the width of hydronephrosis effusion was less than 25mm.
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 |
|---|---|---|
| without reverse ureteral catheter insertionIn contrast to conventional total tubeless percutaneous nephrolithotomy, there was no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no change in position, and no repeated disinfection. | Procedure or surgery | Total tubeless percutaneous nephrolithotomy 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
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 10 Oct 2023.
- 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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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 without reverse ureteral catheter insertion 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 3 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 10 Oct 2023. 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 10 Oct 2023.