Renal StonesNCT04345835
Prone Flexed Position in Percutanous Nephrolithotomy
A study testing Percutanous nephrolithotomy (PCNL) in people with Renal Stones, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Stones
- What is being tested?
- Percutanous nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Large renal or upper ureteral calculi or both,
Who cannot join
- (1) Age <18 years or Pregnancy (2) Ureter pelvic junction obstruction (3) Bilateral simultaneous PCNL (4) Need for 3 percutaneous tracts intraoperative (5) Morbid obesity (BMI >40) (6) Non opaque renal stones. (7)Refuse to complete study requirements (8)Untreated UTI (9)Atypical bowel interposition by CT (10)Tumour in the presumptive access tract area or Potential malignant kidney tumour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Flexed Position in Percutanous Nephrolithotomy in Comparsion With Standard Prone Position. A Randomized Controlled Trial.
prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.
Read the detailed description
Patients meeting the inclusion criteria will be randomly allocated to 2 groups:
- 1st group will undergo prone-flexed PCNL.
- 2nd group will undergo prone PCNL.
III. Recruitment of participants Patients appointed for an outpatient diagnostic cystoscopy will be reviewed for the inclusion and exclusion criteria. Legible patients will be asked to participate in the study and to sign the informed consent form.
IV. Randomisation Randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1 ratio.
- Study procedure Preoperative evaluations included
- Detailed medical history
- Physical examination
- Routine blood examination
- Urinalysis \& urine cytology
- Renal and liver function tests
- Coagulation profile
- Computed tomography of the abdomen and pelvis
Operative Technique
Prone-flexed positioning i. Retrograde access will be obtained ii. The patient is repositioned prone with adequate padding under the pressure points of the head, chest, knees, and feet.
iii. The table is flexed 30 degrees at the level of the patient's mid lumbar region to open the space between the 12th rib and the posterior iliac crest dropping the gluteal muscles from the working plane.
Ancillary intervention
Patients will receive a 20-mL infiltration of 0.25% bupivacaine. Under fluoroscopic guidance, the local analgesic was infiltrated with a 22-gauge spinal needle (10-cm length) along the nephrostomy tract at the 3, 6, 9, and 12 o'clock positions (5 mL in each tract), including the muscles, subcutaneous tissue, and skin.
Patients will receive 1 g tranexamic acid at induction followed by three further doses of 500 mg over the next 24 h.
- Conditions
- Renal Stones
- Being tested
- Percutanous nephrolithotomy (PCNL)
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutanous nephrolithotomy (PCNL)Procedure or surgery
Also called PNL
different procedure positioning
| Study group | Role | What they receive |
|---|---|---|
| prone flexed | Active comparator | prone flexed PCNL position Receives: Procedure: Percutanous nephrolithotomy (PCNL) |
| prone | Active comparator | prone position PCNL Receives: Procedure: Percutanous nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
position complications
Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system
Measured: end of the study
Secondary outcomes (4)
stone score system
Comparison of the Guy's (19)" combines the number of stones, their location, and abnormal patient anatomy into a score 1-4", S.T.O.N.E. (20)"uses the stone size, tract length, obstruction, number of calyces involved, and stone density from patient's preoperative CT scan", and CROES (21) "a continuous variable calculated by stone characteristics, patient data, and surgeon/centre experience" Scores for predicting outcomes following PCNL
Measured: end of the study
stone characteristics
Explore the relationship between stone density using various HU values "highest HU value (HUmax), lowest HU value (HUmin) and average HU value (HUave)"on and outcomes of percutaneous nephrolithotomy (PCNL)
Measured: end of the study
stone volume
Assess the impact of the ellipsoid volume of the stone [volume = π/6*(AP*H*CC)] after measuring the antero-posterior and horizontal dimensions in the axial images and the cranio-caudal dimension in the coronal images on and outcomes of percutaneous nephrolithotomy (PCNL).
Measured: end of the study
hemostatic measures
Investigate the effect of antifibrinolytic tranexamic acid usage on blood loss during PCNL.
Measured: end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University
- Investigators
- Diaa Eldin Taha, MD, Principal investigator, Lecturer of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345835
- Sponsor's protocol ID
- RS/19.20
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Flexed Position in Percutanous Nephrolithotomy in Comparsion With Standard Prone Position. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04345835
- Acronym / sponsor ID
- RS/19.20
- Conditions
- Renal Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 14 Apr 2020 (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.
prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.
Detailed description
Patients meeting the inclusion criteria will be randomly allocated to 2 groups:
- 1st group will undergo prone-flexed PCNL.
- 2nd group will undergo prone PCNL.
III. Recruitment of participants Patients appointed for an outpatient diagnostic cystoscopy will be reviewed for the inclusion and exclusion criteria. Legible patients will be asked to participate in the study and to sign the informed consent form.
IV. Randomisation Randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1 ratio.
- Study procedure Preoperative evaluations included
- Detailed medical history
- Physical examination
- Routine blood examination
- Urinalysis \& urine cytology
- Renal and liver function tests
- Coagulation profile
- Computed tomography of the abdomen and pelvis
Operative Technique
Prone-flexed positioning i. Retrograde access will be obtained ii. The patient is repositioned prone with adequate padding under the pressure points of the head, chest, knees, and feet.
iii. The table is flexed 30 degrees at the level of the patient's mid lumbar region to open the space between the 12th rib and the posterior iliac crest dropping the gluteal muscles from the working plane.
Ancillary intervention
Patients will receive a 20-mL infiltration of 0.25% bupivacaine. Under fluoroscopic guidance, the local analgesic was infiltrated with a 22-gauge spinal needle (10-cm length) along the nephrostomy tract at the 3, 6, 9, and 12 o'clock positions (5 mL in each tract), including the muscles, subcutaneous tissue, and skin.
Patients will receive 1 g tranexamic acid at induction followed by three further doses of 500 mg over the next 24 h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prone flexed | Active comparator | Procedure: Percutanous nephrolithotomy (PCNL)prone flexed PCNL position |
| prone | Active comparator | Procedure: Percutanous nephrolithotomy (PCNL)prone position PCNL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Large renal or upper ureteral calculi or both,
Key exclusion criteria (1 listed)
- (1) Age <18 years or Pregnancy (2) Ureter pelvic junction obstruction (3) Bilateral simultaneous PCNL (4) Need for 3 percutaneous tracts intraoperative (5) Morbid obesity (BMI >40) (6) Non opaque renal stones. (7)Refuse to complete study requirements (8)Untreated UTI (9)Atypical bowel interposition by CT (10)Tumour in the presumptive access tract area or Potential malignant kidney tumour
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 |
|---|---|---|
| Percutanous nephrolithotomy (PCNL)Also: PNLdifferent procedure positioning | Procedure or surgery | prone, prone flexed |
Primary outcome
position complications
Time frame: end of the study
Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system
4 secondary outcomes
stone score system
Time frame: end of the study
stone characteristics
Time frame: end of the study
stone volume
Time frame: end of the study
hemostatic measures
Time frame: end of the study
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 15 Apr 2020.
- 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.
Diaa Eldin Taha, MD principal investigator
Lecturer of urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutanous nephrolithotomy (PCNL) in people with Renal Stones, run by Kafrelsheikh 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 1 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 15 Apr 2020. 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.
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?
position complications (time frame: end of the study). 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 15 Apr 2020.