A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless Percutaneous Nephrolithotomy
Phase: NA
Conditions: Nephrolithotomy, Percutaneous, Kidney Calculi
Sponsor: The First Affiliated Hospital of University of South China

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
A Comparative Study of Retrograde Insertion of a Ureteral
Catheter or Not in Total Tubeless Percutaneous
Nephrolithotomy
NCT number: Waiting for the number
Version number: V3.0
Release date: October 8, 2022

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
1. Title: A Comparative Study of Retrograde Ureteral Catheter Insertion or Not
in Total Tubeless Percutaneous Nephrolithotomy
2. Registered：It is intended to be registered in the International Clinical Trial
Registry (www.clinicaltrials.gov/).
3. Trial protocol version and date: Version3.0/October 8, 2022
4. Funding Project: This study was supported by the Clinical Research Project
of University of South China (USCKF201902K01), and the Hunan Provincial
Clinical Medical Technology Innovation Guiding Project (2020SK51801).
5. Study participants and responsibilities: one experienced associate chief
urologist performed the surgery, and at least 3-5 researchers participated in
data collection and analysis.
6. The research background and theory: Total tubeless Percutneous
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. With the
continuous development of minimally invasive surgery, since the successful
implementation of tubeless PCNL in 1997, several randomized controlled
clinical studies have verified the safety and feasibility of total tubeless PCNL
surgery. With the continuous update of ultrasound equipment and the
continuous progress of physician puncture technology, the application of
ultrasound guided PCNL surgery is more and more popular. Moreover,
ultrasound-guided percutaneous renal aspiration is increasingly independent of
retrograde pyelography or artificial hydronephrosis. Therefore, PCNL without
reverse insertion of a ureteral catheter has been attempted, especially when
patients with severe rheumatoid arthritis or hip ankylosis are clinically
encountered, and the lithotomy position is not possible. Passive PCNL without

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
reverse insertion of ureteral catheter has been successfully performed.
Therefore, it is theoretically feasible to carry out total tubeless PCNL without
reverse insertion of a ureteral catheter for patients with unobstructed urinary
drainage.
7. Study objective: The purpose of this study was to evaluate whether without
retrograde ureteral catheterization is appropriate for total tubeless PCNL.
8. Experimental design: Parallel group design, a total of 2 groups (total tubeless
PCNL group without reverse insertion of a ureteral catheter and conventional
total tubeless PCNL group) were allocated according to 1:1 or approximately
1:1 for exploratory study.
9. Study site: Single-center study, conducted in the Department of Urology, The
First Affiliated Hospital of the University of South China.
10. Inclusion and exclusion criteria: Inclusion criteria: (1) patients with kidney
stones who met the indications for PCNL surgery; (2) the maximum diameter
is less than 35mm; (3) the width of hydronephrosis effusion was less than
25mm. exclusion criteria :(1) patients with infectious calculi confirmed by
preoperative CT examination and blood biochemical indexes; (2) Patients with
severe cardiac and pulmonary insufficiency, coagulation dysfunction and other
obvious surgical contraindications; (3) Patients with previous history of PCNL
surgery on the affected side or nephrotomy; (4) Patients with indwelling
double J tube or nephrostomy tube before operation; (5) Patients with renal
trauma or congenital anomalies of urinary system.
11. Intervention measures: a. Total tubeless PCNL without reverse insertion of a
ureteral catheter and conventional total tubeless PCNL were performed
according to the group, and the same deputy chief physician of urology
performed the operation according to the random group; B. Symptomatic
treatment of patients during perioperative period is allowed, including
antiinfection, analgesia, etc.

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
Total tubeless PCNL without reverse insertion of a ureteral
catheter
implementation process: endotracheal intubation in
patients with general anesthesia, prone position after detaining urethral
catheter, used in ultrasound guided puncture needle percutaneous renal
biopsy to appropriate calyces, under the direct observation of needle in
the renal collecting system, using fascia dilator under guide wire step
by step coaxial expansion of percutaneous renal channel to 16 Fr or 18
Fr. A rigid nephroscope was inserted and the stone was broken by
holmium laser. The crushed stones were removed from the body using
constant flow perfusion during stone crushing and stone removal. After
checking that there was no residual "visible stone", the puncture sheath
was slowly withdrawn, the skin-kidney channel was checked for active
bleeding, and the skin incision was closed with suture.
The implementation process of conventional total tubeless PCNL:
Endotracheal intubation in patients with general anesthesia, patients were
placed in a lithotomy position, and ureteral catheter was inserted reversely
under transurethral ureteroscopy and fixed on the urinary catheter. Then, the
patients were moved to a prone position and were disinfected again, under the
guidance of ultrasound in establishing a channel process and stone removal
process was the same as that in total tubeless PCNL without reverse insertion
of a ureteral catheter, after inspection without the "visible" stone of residual,
The puncture sheath was slowly withdrawn, the passage was checked for
active bleeding, and the skin incision was closed with suture.
12. Outcome indicators: The primary end point was the rate of postoperative
complications, Observation indexes including postoperative fever,
inflammation index change (postoperative blood leukocytes and neutrophils
ratio changes value), hemorrhage (postoperative hemoglobin change value, red
blood cell pressure change value and the incidence of renal subcapsular
hematoma), kidney damage (postoperative serum creatinine change value),

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
pain (postoperative VAS pain score, non-steroidal anti-inflammatory analgesic
and opioids Rate) and the incidence of pleural effusion. Secondary end points
included stone free rate, operation time, postoperative hospital stay, and
hospital costs.
13. Study flow charts
14. Sample size: a total of 100 subjects are expected to be included (50 in each
group).
15. Recruitment of study subjects: Recruiting research subjects were conducted
by a researcher in the Urology Clinic of the First Affiliated Hospital of the
University of South China.
16. Allocation sequence generation and implementation method: A researcher
was assigned to the group by random number method (odd number represents
the conventional tubeless PCNL, and even number represents the total tubeless
PCNL without reverse insertion of a ureteral catheter), which took place in the
operating room.

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
17. Blinding method: single-blind, the enrolled patients were only told that they
could receive either of the two surgical procedures, and the specific surgical
method was determined by random number table method after entering the
operating room.
18. Data collection.
All datato
be
measured:
1.
Demographic
data,
stone characteristics, and preoperative baseline data, Including the proportion
of gender, age, body mass index (BMI) and basic diseases distribution,
location, stones, stone maximum cross-sectional area, the width of
hydronephrosis, preoperative hemoglobin, Preoperative hematocrit,
preoperative blood leukocyte count, preoperative blood neutrophils ratio,
preoperative serum creatinine, urine leucocyte, site of puncture and operation
laterality, 2. The primary end point of this study was the rate of postoperative
complications, compared according to the modified Clavien-Dindo
complication grading system. Observation indexes including postoperative
fever, inflammation index change (postoperative blood leukocytes and
neutrophils ratio changes value), hemorrhage (value changes of postoperative
hemoglobin, red blood cell pressure change value and the incidence of renal
subcapsular hematoma), kidney damage (postoperative serum creatinine values
change), pain (VAS pain score, non-steroidal anti-inflammatory analgesic, and
opioids demand rate) and the incidence of pleural effusion. Secondary end
points included stone clearance rate, operation duration, postoperative hospital
stay, and hospital costs. 3. Follow-up data included pain, hematuria, fever and
readmission for 3 months after operation. Three researchers conducted data
statistics respectively and obtained three original data, which were finally
averaged.
19. Statistical analysis plan: SPSS26.0 version statistical software was used for
analysis. 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

Research Project: No. USCKF201902K01、2020SK51801
Version number: V3.0
Release date:October 8, 2022
Fisher's exact probability test was used for intergroup comparisons. The
ranksum test was used for grade data. P<0.05 was considered statistically
significant.
20. Approval of informed consent and ethics: This study followed the ethical
standards set out in the Declaration of Helsinki. Informed consent was
obtained and signed by all enrolled patients to undergo the two surgical
procedures (total tubeless PCNL without reverse insertion of a ureteral catheter
and conventional total tubeless PCNL) and to collect and use the medical
information and biological samples for the study.
21. Confidentiality measures: The identifiable information of the subjects is
replaced by irrelevant character sequences to ensure that the relevant personal
information of the subjects will not be disclosed in any form.
22. Declaration of Interest: There is no conflict of interest between the
investigator and the organization.
23. Data Acquisition: When proper editing or review requirements are met, the
study data may be obtained from the study manager after the study is
completed.