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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group(group 1) | Experimental | Percutaneous nephrolithotripsy was performed using one - hand lithotripsy |
|
| Control group(group 2) | No Intervention | Percutaneous nephrolithotripsy was performed using traditional techniques |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| one-handed technique | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | From the completion of anesthesia to the end of the suture incision. | 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%) | Day 2 after the surgery |
| Renal pelvis mucosal injury rate | Number of accidental injuries of renal pelvis mucosa during operation | during the procedure |
| Changes in renal bleeding after surgery | Pre- vs. post-operative difference in hemoglobin and hematocrit values | Hour 3 after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital costs | The cost from hospitalization to discharge. | immediately after the discharge |
| Hospital stay | The number of days from hospitalization to discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingyong Li, MD | Contact | 18175878363 | myli1123@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingyong Li, MD | The First Affiliated Hospital of University of South China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of South China | Recruiting | Hengyang | Hunan | 42100 | China |
All individual participant data that underlie results in a publication.
Starting 1 year after publication.
When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2022 | Dec 9, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Participants are randomly assigned to an experimental or control group in parallel.
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A single-blind trial in which participants were unaware of the study group and the intervention.
|
| immediately after the discharge |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |