Percutaneous NephrolithotomyNCT03907930
Conventional PCNL Versus Tubeless PCNL
A study testing percutaneous nephrolithotripsy in people with Percutaneous Nephrolithotomy, run by Assiut University at 1 site in Egypt.
Trial summary
prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- percutaneous nephrolithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2019to May 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure
Who cannot join
- 1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.
- 3. Complex or staghorn stones requiring staged procedure.
- Intra operative criteria:
- 4. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University Hospitals
Asyut
mohamed zowita, doctor, 01006769102, maaszo@gmail.com
About this study
Official title: Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)
prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL
Read the detailed description
Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications.
Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.
This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- percutaneous nephrolithotripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrolithotripsyProcedure or surgery
Also called PCNL
removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | this arm will have both nephrostomy tube and ureteric catheter after completing the operation Receives: Procedure: percutaneous nephrolithotripsy |
| tubeless | Active comparator | the arm will have only ureteric catheter rafter completing the operation Receives: Procedure: percutaneous nephrolithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days of hospital stay for both groups
comparison between number of days in hospital for both groups
Measured: 15 days
dose of analgesia used to control pain after the procedure
comparison between the dose of analgesia needed for both groups in milligram
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start28 Mar 2019
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous NephrolithotomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Alsayed Ahmed Zowita, Assiut University
- Investigators
- atef abd aziz, professor, Study chair, assuit university hospital urology departement egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907930
- Sponsor's protocol ID
- tubeless PCNL
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
PubMed 1006190Valdivia Uria JG, Valle Gerhold J, Lopez Lopez JA, Villarroya Rodriguez S, Ambroj Navarro C, Ramirez Fabian M, Rodriguez Bazalo JM, Sanchez Elipe MA. Technique and complications of percutaneous nephroscopy: experience with 557 patients in the supine position. J Urol. 1998 Dec;160(6 Pt 1):1975-8. doi: 10.1016/s0022-5347(01)62217-1.
PubMed 9817303
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Tubeless and Standard Percutaneous Nephrolithotomy. Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT03907930
- Acronym / sponsor ID
- tubeless PCNL
- Conditions
- Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 9 Apr 2019 (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.
prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL
Detailed description
Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications.
Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.
This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Procedure: percutaneous nephrolithotripsythis arm will have both nephrostomy tube and ureteric catheter after completing the operation |
| tubeless | Active comparator | Procedure: percutaneous nephrolithotripsythe arm will have only ureteric catheter rafter completing the operation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure
Key exclusion criteria (4 listed)
- 1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.
- 3. Complex or staghorn stones requiring staged procedure.
- 4. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL
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 nephrolithotripsyAlso: PCNLremoval of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast | Procedure or surgery | conventional, tubeless |
Primary outcome
number of days of hospital stay for both groups
Time frame: 15 days
comparison between number of days in hospital for both groups
dose of analgesia used to control pain after the procedure
Time frame: 5 days
comparison between the dose of analgesia needed for both groups in milligram
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Background: PubMed 1006190Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
- Background: PubMed 9817303Valdivia Uria JG, Valle Gerhold J, Lopez Lopez JA, Villarroya Rodriguez S, Ambroj Navarro C, Ramirez Fabian M, Rodriguez Bazalo JM, Sanchez Elipe MA. Technique and complications of percutaneous nephroscopy: experience with 557 patients in the supine position. J Urol. 1998 Dec;160(6 Pt 1):1975-8. doi: 10.1016/s0022-5347(01)62217-1.
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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.
atef abd aziz, professor study chair
assuit university hospital urology departement egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous nephrolithotripsy in people with Percutaneous Nephrolithotomy, 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 4 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 9 Apr 2019. 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 mohamed zowita, doctor (01006769102, maaszo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days of hospital stay for both groups (time frame: 15 days). 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 NCT03907930, which also lists 2 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 9 Apr 2019.