Percutaneous NephrolithotomyNCT05661175
Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy
A study testing one-handed technique in people with Percutaneous Nephrolithotomy, run by The First Affiliated Hospital of University of South China at 1 site in China.
Trial summary
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi.Traditional percutaneous nephrolithotomy usually requires the lithotripsy with the left hand holding the nephroscope and the right hand adjusting the laser fiber,which requires a lot of practice to master this technique.The goal of this… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- one-handed technique
- 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
- 3 Dec 2022to 3 Nov 2023
- 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
- Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Disease.
- Participants who agree to undergo one-hand lithotripsy.
Who cannot join
- Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function.
- Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
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, 42100
Li Mingyong, MD, 18175878363, myli1123@126.com
Li Mingyong, MD
About this study
Official title: A Comparative Study of One-handed Lithotripsy and Traditional Lithotripsy in Percutaneous Nephrolithotomy
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi.Traditional percutaneous nephrolithotomy usually requires the lithotripsy with the left hand holding the nephroscope and the right hand adjusting the laser fiber,which requires a lot of practice to master this technique.The goal of this study is to explore the safety and effectiveness of the PCNL with one-handed lithotripsy technique
Read the detailed description
This is a key clinical research project of the University of South China(NO.USCKF201902K01).The goal of this study is to compare the safety,effectiveness and feasibility between the percutaneous nephrolithotomy with one-handed technique and the traditional percutaneous nephrolithotomy in the treatment of upper urinary calculi. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation.For random allocation,participants are randomly grouped by coin toss method.Participants with front side are assigned to experimental group,where they undergo PCNL with one-handed lithotripsy.Participants with reverse side are assigned to control group and undergo traditional PCNL.The doctors managing the operations accept participants and execute the surgical treatments.All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation.Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- one-handed technique
- Keywords
- Percutaneous nephrolithotomy, one-handed lithotripsy, Urinary calculi, traditional PCNL
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-handed techniqueProcedure or surgery
Traditional percutaneous nephrolithotripsy usually requires the left hand to hold the nephroscope and the right hand to control the fiber for lithotripsy.Our intervention is to control the depth and direction of the sheath with the left hand, the nephroscope in the right hand and control the fiber optic lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group(group 1) | Experimental | Percutaneous nephrolithotripsy was performed using one - hand lithotripsy Receives: Procedure: one-handed technique |
| Control group(group 2) | No intervention | Percutaneous nephrolithotripsy was performed using traditional techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
From the completion of anesthesia to the end of the suture incision.
Measured: during the procedure
Stone clearance rate
Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi < 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%)
Measured: Day 2 after the surgery
Renal pelvis mucosal injury rate
Number of accidental injuries of renal pelvis mucosa during operation
Measured: during the procedure
Changes in renal bleeding after surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
Measured: Hour 3 after the surgery
Secondary outcomes (2)
Hospital costs
The cost from hospitalization to discharge.
Measured: immediately after the discharge
Hospital stay
The number of days from hospitalization to discharge
Measured: immediately after the discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start3 Dec 2022
- Primary completion3 Nov 2023 (estimated)
- Study completion3 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies 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
- Model description
- Participants are randomly assigned to an experimental or control group in parallel.
- 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, Principal investigator, The First Affiliated Hospital of University of South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661175
- Sponsor's protocol ID
- USCKF202011K20
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of One-handed Lithotripsy and Traditional Lithotripsy in Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05661175
- Acronym / sponsor ID
- USCKF202011K20
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Percutaneous nephrolithotomy, one-handed lithotripsy, Urinary calculi, traditional PCNL
- 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
- 3 Dec 2022 (actual)
- Primary completion
- 3 Nov 2023 (estimated)
- Study completion
- 3 Nov 2023 (estimated)
- First posted
- 22 Dec 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.
Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi.Traditional percutaneous nephrolithotomy usually requires the lithotripsy with the left hand holding the nephroscope and the right hand adjusting the laser fiber,which requires a lot of practice to master this technique.The goal of this study is to explore the safety and effectiveness of the PCNL with one-handed lithotripsy technique
Detailed description
This is a key clinical research project of the University of South China(NO.USCKF201902K01).The goal of this study is to compare the safety,effectiveness and feasibility between the percutaneous nephrolithotomy with one-handed technique and the traditional percutaneous nephrolithotomy in the treatment of upper urinary calculi. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation.For random allocation,participants are randomly grouped by coin toss method.Participants with front side are assigned to experimental group,where they undergo PCNL with one-handed lithotripsy.Participants with reverse side are assigned to control group and undergo traditional PCNL.The doctors managing the operations accept participants and execute the surgical treatments.All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation.Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to an experimental or control group in parallel.
| Arm | Type | Receives |
|---|---|---|
| Experimental group(group 1) | Experimental | Procedure: one-handed techniquePercutaneous nephrolithotripsy was performed using one - hand lithotripsy |
| Control group(group 2) | No intervention | –Percutaneous nephrolithotripsy was performed using traditional techniques |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Disease.
- Participants who agree to undergo one-hand lithotripsy.
Key exclusion criteria (2 listed)
- Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function.
- Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
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 |
|---|---|---|
| one-handed techniqueTraditional percutaneous nephrolithotripsy usually requires the left hand to hold the nephroscope and the right hand to control the fiber for lithotripsy.Our intervention is to control the depth and direction of the sheath with the left hand, the nephroscope in the right hand and control the fiber optic lithotripsy | Procedure or surgery | Experimental group(group 1) |
Primary outcome
Operative time
Time frame: during the procedure
From the completion of anesthesia to the end of the suture incision.
Stone clearance rate
Time frame: Day 2 after the surgery
Preoperative and postoperative stone dimensions are compared by radiological assessment. Postoperative residual calculi < 4 mm in diameter reflect complete removal of calculi (stone-free rate = 100%)
Renal pelvis mucosal injury rate
Time frame: during the procedure
Number of accidental injuries of renal pelvis mucosa during operation
Changes in renal bleeding after surgery
Time frame: Hour 3 after the surgery
Pre- vs. post-operative difference in hemoglobin and hematocrit values
2 secondary outcomes
Hospital costs
Time frame: immediately after the discharge
Hospital stay
Time frame: immediately after the discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication.
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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 principal investigator
The First Affiliated Hospital of 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 one-handed technique in people with Percutaneous Nephrolithotomy, 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 2 inclusion and 2 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 Mar 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 (18175878363, myli1123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: during the procedure). The study lists 4 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 Mar 2023.