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Can a smaller incision for kidney stone surgery reduce recovery without sacrificing results?

NCT ID NCT07697677

Disease control Sponsor: The First Affiliated Hospital of Guangzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial compares two surgical techniques for removing large or complex kidney stones: a modified mini version using a smaller access sheath (20 Fr) versus the standard approach (24 Fr). The goal is to see if the mini procedure causes less bleeding and pain while still clearing stones just as effectively. About 1,380 adults with complex kidney stones will be randomly assigned to one of the two procedures across eight hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified mini percutaneous nephrolithotomy (mini-PCNL) using a 20 Fr access sheath
What this could lead to
If successful, this could offer a less invasive surgical option for complex kidney stones, reducing bleeding, pain, and recovery time while still effectively clearing stones.
What could go wrong
This is a comparative effectiveness trial, not a new drug or device. The mini approach may not clear stones as well as the standard method, or benefits may be modest. Results depend on surgeon skill and patient anatomy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,380 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged ≥18 years. 2. Serum creatinine ≤133 μmol/L. 3. American Society of Anesthesiologists (ASA) physical status classification I-III. 4. S.T.O.N.E. score ≥8. 5. Complex renal stones confirmed by noncontrast computed tomography, including stone surface area \>1500 mm², multiple calyceal stones, partial or complete staghorn calculi, or complex anatomical conditions. 6. Patients who provide written informed consent and agree to undergo either modified mini-percutaneous nephrolithotomy or standard percutaneous nephrolithotomy. Exclusion Criteria: 1. Solitary kidney. 2. Morbid obesity (body mass index ≥35 kg/m²). 3. Previous renal transplantation or urinary diversion. 4. Congenital abnormalities of the urinary tract. 5. Pregnancy. 6. Uncorrected coagulopathy. 7. Active urinary tract infection.

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex renal calculi Kidney stones

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510120, China

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