Renal StonePhase 2/3NCT04869969
Supine Percutaneous Nephrolithotomy
A Phase 2/3 study testing percutaneous nephrolithotomy (supine position) and percutaneous nephrolithotomy ( prone position) in people with Renal Stone, run by Ain Shams University at 1 site in Egypt.
Trial summary
there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Renal Stone
- What is being tested?
- percutaneous nephrolithotomy (supine position) and percutaneous nephrolithotomy ( prone position)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 30 Sep 2021
- Phase
- Phase 2/3
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy
Who cannot join
- patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention.
- patients with skeletal abnormalities and spine deformities were also excluded
- patients with a single kidney were also excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.
there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.
Read the detailed description
The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury.
Supine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position.
our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.
- Conditions
- Renal Stone
- Being tested
- percutaneous nephrolithotomy (supine position), percutaneous nephrolithotomy ( prone position)
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrolithotomy (supine position)Procedure or surgery
percutaneous nephrolithotomy to be done in the supine position
percutaneous nephrolithotomy ( prone position)Procedure or surgery
percutaneous nephrolithotomy in the prone position
| Study group | Role | What they receive |
|---|---|---|
| supine percutaneous nephrolithotomy | Experimental | percutaneous nephrolithotomy to be done in the supine position Receives: Procedure: percutaneous nephrolithotomy (supine position) |
| prone percutaneous nephrolithotomy | Active comparator | percutaneous nephrolithotomy to be done in the prone position Receives: Procedure: percutaneous nephrolithotomy ( prone position) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
evaluation of our patients after surgery with Xray or CT to detect residual stones
Measured: first day postoperative
Secondary outcomes (10)
Fluoroscopy time during the procedure in minutes
time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only
Measured: intraoperative finding in minutes,
operative time of the procedure in minutes
time from patient positioning till the end of the procedure, operative finding only
Measured: intraoperative finding in minutes,
rate of Hemoglobin drop
change in the perioperative hemoglobin level
Measured: day 1 post operative
hospital stay
days of hospital stay after the surgery
Measured: first 2 days post surgery
incidence of urinary tract infection
presence of manifested urinary tract infection in our patient
Measured: first 7 days post surgery
urine leakage
urine leakage from the percutaneous renal tract
Measured: first 3 days postoperative
irrigation fluid usage
amount of irrigation fluid used during the surgery in liters
Measured: intraoperative finding
postoperative fever
incidence of postoperative fever more than 38 c
Measured: first 2 days post surgery
need for DJ application
the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones
Measured: intraoperative finding
incidence of intraoperative colonic injury
the accident injury to adjacent colon
Measured: intraoperative finding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jun 2019
- Primary completion1 Jan 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- percutaneous nephrolithotomy to be performed in both supine and prone position
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869969
- Sponsor's protocol ID
- R32/ 2019
- Status last verified
- Jul 2022
- First submitted
- 6 Mar 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04869969
- Acronym / sponsor ID
- R32/ 2019
- Conditions
- Renal Stone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 May 2021 (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.
there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.
Detailed description
The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury.
Supine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position.
our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- percutaneous nephrolithotomy to be performed in both supine and prone position
| Arm | Type | Receives |
|---|---|---|
| supine percutaneous nephrolithotomy | Experimental | Procedure: percutaneous nephrolithotomy (supine position)percutaneous nephrolithotomy to be done in the supine position |
| prone percutaneous nephrolithotomy | Active comparator | Procedure: percutaneous nephrolithotomy ( prone position)percutaneous nephrolithotomy to be done in the prone position |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy
Key exclusion criteria (3 listed)
- patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention.
- patients with skeletal abnormalities and spine deformities were also excluded
- patients with a single kidney were also excluded
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 |
|---|---|---|
| percutaneous nephrolithotomy (supine position)percutaneous nephrolithotomy to be done in the supine position | Procedure or surgery | supine percutaneous nephrolithotomy |
| percutaneous nephrolithotomy ( prone position)percutaneous nephrolithotomy in the prone position | Procedure or surgery | prone percutaneous nephrolithotomy |
Primary outcome
stone free rate
Time frame: first day postoperative
evaluation of our patients after surgery with Xray or CT to detect residual stones
10 secondary outcomes
Fluoroscopy time during the procedure in minutes
Time frame: intraoperative finding in minutes,
operative time of the procedure in minutes
Time frame: intraoperative finding in minutes,
rate of Hemoglobin drop
Time frame: day 1 post operative
hospital stay
Time frame: first 2 days post surgery
incidence of urinary tract infection
Time frame: first 7 days post surgery
urine leakage
Time frame: first 3 days postoperative
irrigation fluid usage
Time frame: intraoperative finding
postoperative fever
Time frame: first 2 days post surgery
need for DJ application
Time frame: intraoperative finding
incidence of intraoperative colonic injury
Time frame: intraoperative finding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing percutaneous nephrolithotomy (supine position) and percutaneous nephrolithotomy ( prone position) in people with Renal Stone, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2022. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate (time frame: first day postoperative). 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 14 Jul 2022.