search
Back to results

Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

Primary Purpose

Nephrolithotomy, Percutaneous, Kidney Calculi

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
without reverse ureteral catheter insertion
Sponsored by
The First Affiliated Hospital of University of South China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithotomy, Percutaneous

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The First Affiliated Hospital of University of South ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter

Conventional total tubeless percutaneous nephrolithotomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of fever
Fever was defined as axillary temperature greater than 38.5 ° C.
White blood cell count change value
The change value of White blood cell count between preoperative and
Neutrophils granulocyte change value
The change value of Neutrophils granulocyte between preoperative and postoperative
Hemoglobin change value
The change value of Hemoglobin between preoperative and postoperative
Hematocrit change value
The change value of Hematocrit between preoperative and postoperative
Rate of renal subcapsular hematoma
The proportion of postoperative renal subcapsular hematoma in all patients
Serum creatinine change value
The change value of Serum creatinine between preoperative and postoperative
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.
Rate of hydrothorax
Hydrothorax appeared on the surgical side.

Secondary Outcome Measures

Stone free rate
Residual stone less than 4mm in diameter was considered to have been cleared.
Operation time
Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture.
length of hospital stay
Length of hospital stay indicated the number of days between the operation date and discharge date
Medical costs
All medical expenses incurred to treat stones.

Full Information

First Posted
October 6, 2022
Last Updated
October 9, 2023
Sponsor
The First Affiliated Hospital of University of South China
search

1. Study Identification

Unique Protocol Identification Number
NCT05578807
Brief Title
Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter
Official Title
A Comparative Study of Retrograde Ureteral Catheter Insertion or Not in Total Tubeless Percutaneous Nephrolithotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
October 10, 2024 (Anticipated)
Study Completion Date
January 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of University of South China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithotomy, Percutaneous, Kidney Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional total tubeless percutaneous nephrolithotomy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
without reverse ureteral catheter insertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of fever
Description
Fever was defined as axillary temperature greater than 38.5 ° C.
Time Frame
From the day of surgery to the day of discharge, up to 2 weeks.
Title
White blood cell count change value
Description
The change value of White blood cell count between preoperative and
Time Frame
Day 2 before surgery、hour 3 after the surgery
Title
Neutrophils granulocyte change value
Description
The change value of Neutrophils granulocyte between preoperative and postoperative
Time Frame
Day 2 before surgery、hour 3 after the surgery
Title
Hemoglobin change value
Description
The change value of Hemoglobin between preoperative and postoperative
Time Frame
Day 2 before surgery、hour 3 after the surgery
Title
Hematocrit change value
Description
The change value of Hematocrit between preoperative and postoperative
Time Frame
Day 2 before surgery、hour 3 after the surgery
Title
Rate of renal subcapsular hematoma
Description
The proportion of postoperative renal subcapsular hematoma in all patients
Time Frame
Day 2 after the surgery
Title
Serum creatinine change value
Description
The change value of Serum creatinine between preoperative and postoperative
Time Frame
Day 2 before surgery、Hour 3 after the surgery
Title
visual analog scale (VAS)pain score
Description
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.
Time Frame
Hour 2 after the surgery
Title
Rate of hydrothorax
Description
Hydrothorax appeared on the surgical side.
Time Frame
Day 2 after the surgery
Secondary Outcome Measure Information:
Title
Stone free rate
Description
Residual stone less than 4mm in diameter was considered to have been cleared.
Time Frame
Day 2 after the surgery
Title
Operation time
Description
Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture.
Time Frame
During the procedure
Title
length of hospital stay
Description
Length of hospital stay indicated the number of days between the operation date and discharge date
Time Frame
2 weeks after surgery
Title
Medical costs
Description
All medical expenses incurred to treat stones.
Time Frame
2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyong Li, MD.
Phone
137-8648-4606
Ext
+86
Email
myli1123@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingyong Li, MD.
Organizational Affiliation
the First Affiliated Hospital of the University of South China
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyong Li
Phone
18175878363
Ext
+86
Email
myli1123@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be made available to other researchers after the study Report are published.
IPD Sharing Time Frame
One year after the study report was published,but the duration is uncertain.
IPD Sharing Access Criteria
When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.

Learn more about this trial

Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

We'll reach out to this number within 24 hrs