EndourologyNCT04846699
Triangulation Bulls Eye and Stone Direct Targeting Pcnl
An observational study of Endourology, run by Assiut University at 1 site in Egypt.
Trial summary
To assess the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted techniques in the following:- 1. Stone free rate (SFR) (primary outcome). 2. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Endourology
- What is being tested?
- per-cutaneous stone extraction
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2021to 20 Apr 2023
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Adult
Study population: all patients presented to endourology clinic by renal stone and complianting and fit for surgery.
Who may be able to join
- The study will include all adult patients that with renal stones larger than 2 cm in diameter who will attend our endourology outpatient clinic from Jan 2021 to February 2023 and consented to participate in the study.
Who cannot join
- 1-Patients with urinary system anomalies as horseshoe kidney, ectopic pelvic kid.
- 2-Patients with skeletal malformations. 3-Bleeding tendency and ongoing anticoagulant therapy. 4-Pregnancy. 5-Patients who refuse to be involved in the trial documentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triangulation, Eye of the Needle and Stone Direct Targeting Percutaneous Renal Access Techniques of Nephrolithotomy : Randomized Controlled Trial
To assess the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted techniques in the following:-
- Stone free rate (SFR) (primary outcome).
- Complicatins of surgery (primary outcome).
- Change in haematocrit pre and postoperative (secondary outcome).
- Operative time (secondary outcome).
- Duration of hospitalization (secondary outcome). .
7-Fluroscpic screening time (FST) (secondary outcome). . 8- Change in haematocrit pre and postoperative (secondary outcome).
Read the detailed description
Percutaneous nephrolithotomy (PNL) is an appropriate first-line alternative for the management of kidney stones that are larger than 2 cm in diameter and that do not respond to extracorporeal shock wave lithotripsy (SWL) [1,2].
Percutaneous renal access is the most important step in PNL, and the adequacy of access directly affects the success and complication rates of this procedure.
Among C-arm fluoroscopy, computed tomography (CT), and ultrasonography (US), C-arm fluoroscopy is the most commonly used imaging technique to access the intrarenal collecting system [3-4].
Various fluoroscopy techniques have been described for achieving a good access. One can use fluoroscopy or ultrasonography or a combination of both for reaching the target calyx. Each of it has its advantages and disadvantages, and no consensus exists showing the superiority of one or the other [5].
Triangulation and ''eye of the needle'' (or bull's eye) techniques are two common methods to obtain proper percutaneous renal access under fluoroscopy guidance [6-7].
Multiplanar fluoroscopic imaging is essential in both techniques to make a proper renal puncture.
Biplanar access is based on mediolateral and cephalad-caudal movements of the needle, with the depth of the puncture adjusted based on different fluoroscopic projections, including oblique, vertical, and 30° positions [6, 8].
Most published studies of PCNL have focused on evaluating the effect of patient- and stone-related factors such as success rate, extent of bleeding, complication rate, fluoroscopic Screening times (FSTs), and operative time on outcomes. [9-10]
The imaging modalities used for guidance by urologists or radiologists during percutaneous renal access and renal access procedures have also recently been analyzed and compared in terms of outcomes and complications.[11-12]
These studies, however, have not considered the effect of percutaneous renal access technique on outcome. Although the triangulation and the bull's-eye techniques have been evaluated and compared using a biologic model in a published study [13], no clinical study comparing these techniques has been performed.
The aim of this study is to evaluate the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted technique .
- Conditions
- Endourology
- Being tested
- per-cutaneous stone extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
per-cutaneous stone extractionProcedure or surgery
percutaneous nephrolithotripsy for renal stones by different renal access
| Study group | Role | What they receive |
|---|---|---|
| group 1 | bulls eye localization Receives: Procedure: per-cutaneous stone extraction | |
| group 2 | stone targeted technique renal access Receives: Procedure: per-cutaneous stone extraction | |
| group 3 | triangulation renal access technique Receives: Procedure: per-cutaneous stone extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
outcome of residual stone postoperative
Measured: 48 hours postoperative
complication of surgery
fever , urine leakage , stent of ureter , sepsis, other intervention
Measured: from day one post-operative to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start20 Apr 2021 (estimated)
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndourologyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud eldardery, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846699
- Sponsor's protocol ID
- new pcnl approch
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmahl FW, Betz E, Talke H, Hohorst HJ. [Energy rich phosphates and metabolites of energy metabolism in the cerebral cortex in the cat]. Biochem Z. 1965 Sep 30;342(5):518-31. No abstract available. German.
PubMed 5866850Ashley FL. Implications of wound healing research. A meeting ground for experimental biology and clinical medicine. Plast Reconstr Surg. 1969 Feb;43(2):190-1. No abstract available.
PubMed 5765923Meshkov SL, Seltzer SE, Finberg HJ. CT detection of intraabdominal disease in patients with lower extremity signs and symptoms. J Comput Assist Tomogr. 1982 Jun;6(3):497-501. doi: 10.1097/00004728-198206000-00010.
PubMed 7096695
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triangulation, Eye of the Needle and Stone Direct Targeting Percutaneous Renal Access Techniques of Nephrolithotomy : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04846699
- Acronym / sponsor ID
- new pcnl approch
- Conditions
- Endourology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (estimated)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 15 Apr 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.
To assess the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted techniques in the following:-
- Stone free rate (SFR) (primary outcome).
- Complicatins of surgery (primary outcome).
- Change in haematocrit pre and postoperative (secondary outcome).
- Operative time (secondary outcome).
- Duration of hospitalization (secondary outcome). .
7-Fluroscpic screening time (FST) (secondary outcome). . 8- Change in haematocrit pre and postoperative (secondary outcome).
Detailed description
Percutaneous nephrolithotomy (PNL) is an appropriate first-line alternative for the management of kidney stones that are larger than 2 cm in diameter and that do not respond to extracorporeal shock wave lithotripsy (SWL) [1,2].
Percutaneous renal access is the most important step in PNL, and the adequacy of access directly affects the success and complication rates of this procedure.
Among C-arm fluoroscopy, computed tomography (CT), and ultrasonography (US), C-arm fluoroscopy is the most commonly used imaging technique to access the intrarenal collecting system [3-4].
Various fluoroscopy techniques have been described for achieving a good access. One can use fluoroscopy or ultrasonography or a combination of both for reaching the target calyx. Each of it has its advantages and disadvantages, and no consensus exists showing the superiority of one or the other [5].
Triangulation and ''eye of the needle'' (or bull's eye) techniques are two common methods to obtain proper percutaneous renal access under fluoroscopy guidance [6-7].
Multiplanar fluoroscopic imaging is essential in both techniques to make a proper renal puncture.
Biplanar access is based on mediolateral and cephalad-caudal movements of the needle, with the depth of the puncture adjusted based on different fluoroscopic projections, including oblique, vertical, and 30° positions [6, 8].
Most published studies of PCNL have focused on evaluating the effect of patient- and stone-related factors such as success rate, extent of bleeding, complication rate, fluoroscopic Screening times (FSTs), and operative time on outcomes. [9-10]
The imaging modalities used for guidance by urologists or radiologists during percutaneous renal access and renal access procedures have also recently been analyzed and compared in terms of outcomes and complications.[11-12]
These studies, however, have not considered the effect of percutaneous renal access technique on outcome. Although the triangulation and the bull's-eye techniques have been evaluated and compared using a biologic model in a published study [13], no clinical study comparing these techniques has been performed.
The aim of this study is to evaluate the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted technique .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: per-cutaneous stone extractionbulls eye localization |
| group 2 | – | Procedure: per-cutaneous stone extractionstone targeted technique renal access |
| group 3 | – | Procedure: per-cutaneous stone extractiontriangulation renal access technique |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- all patients presented to endourology clinic by renal stone and complianting and fit for surgery.
Key inclusion criteria (1 listed)
- The study will include all adult patients that with renal stones larger than 2 cm in diameter who will attend our endourology outpatient clinic from Jan 2021 to February 2023 and consented to participate in the study.
Key exclusion criteria (2 listed)
- 1-Patients with urinary system anomalies as horseshoe kidney, ectopic pelvic kid.
- 2-Patients with skeletal malformations. 3-Bleeding tendency and ongoing anticoagulant therapy. 4-Pregnancy. 5-Patients who refuse to be involved in the trial documentation.
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 |
|---|---|---|
| per-cutaneous stone extractionpercutaneous nephrolithotripsy for renal stones by different renal access | Procedure or surgery | group 1, group 2, group 3 |
Primary outcome
stone free rate
Time frame: 48 hours postoperative
outcome of residual stone postoperative
complication of surgery
Time frame: from day one post-operative to 3 months
fever , urine leakage , stent of ureter , sepsis, other intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 5866850Schmahl FW, Betz E, Talke H, Hohorst HJ. [Energy rich phosphates and metabolites of energy metabolism in the cerebral cortex in the cat]. Biochem Z. 1965 Sep 30;342(5):518-31. No abstract available. German.
- Background: PubMed 5765923Ashley FL. Implications of wound healing research. A meeting ground for experimental biology and clinical medicine. Plast Reconstr Surg. 1969 Feb;43(2):190-1. No abstract available.
- Background: PubMed 7096695Meshkov SL, Seltzer SE, Finberg HJ. CT detection of intraabdominal disease in patients with lower extremity signs and symptoms. J Comput Assist Tomogr. 1982 Jun;6(3):497-501. doi: 10.1097/00004728-198206000-00010.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endourology, run by Assiut 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 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 15 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahmoud abdo eldardery (01008763519, m.eldardery91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate (time frame: 48 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846699, which also lists 3 linked publications.
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 2021.