Percutaneous Nephrolithotomy Without a Ureteral Catheter

February 24, 2024 updated by: Li Mingyong, MD, The First Affiliated Hospital of University of South China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mingyong Li, MD.
  • Phone Number: +86 137-8648-4606
  • Email: myli1123@126.com

Study Locations

  • China
    • Hunan
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

· Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: without reverse insertion of a ureteral catheter
Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter
Procedure: PCNL without reverse insertion of a ureteral catheter
The ureteral catheter was not retrograde inserted during PCNL
No Intervention: Conventional
Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the day of surgery to the day of discharge, up to 2 weeks.
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
Day 2 before surgery、hour 3 after the surgery
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
Day 2 before surgery、hour 3 after the surgery
Hemoglobin change value
Time Frame: Day 2 before surgery、hour 3 after the surgery
The change value of Hemoglobin between preoperative and postoperative
Day 2 before surgery、hour 3 after the surgery
Hematocrit change value
Time Frame: Day 2 before surgery、hour 3 after the surgery
The change value of Hematocrit between preoperative and postoperative
Day 2 before surgery、hour 3 after the surgery
Rate of renal subcapsular hematoma
Time Frame: Day 2 after the surgery
The proportion of postoperative renal subcapsular hematoma in all patients
Day 2 after the surgery
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
Day 2 before surgery、Hour 3 after the surgery
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.
Hour 2 after the surgery
Rate of hydrothorax
Time Frame: Day 2 after the surgery
Hydrothorax appeared on the surgical side.
Day 2 after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: Day 2 after the surgery
Residual stone less than 4mm in diameter was considered to have been cleared.
Day 2 after the surgery
Operation time
Time Frame: During the procedure
Operation time was defined as the time required from the surgeon's handwashing to the completion of surgical incision suture
During the procedure
length of hospital stay
Time Frame: 2 weeks after surgery
Length of hospital stay indicated the number of days between the operation date and discharge date
2 weeks after surgery
Medical costs
Time Frame: 2 weeks after surgery
All medical expenses incurred to treat stones.
2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of University of South China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mingyong Li, MD., the First Affiliated Hospital of the University of South China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • nhfy0520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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