PCNLNCT05640219
Novel Technique for PCNL Access
A study testing laparoscopic trocar 12mm in people with PCNL, run by Benha University.
Trial summary
Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our modification aims to decrease the complications of PCNL in large stones Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PCNL
- What is being tested?
- laparoscopic trocar 12mm
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2023to 17 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/ the upper calyx in patints 18 years old or more
Who cannot join
- patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn
About this study
Official title: Benha Modification for Renal Track Creation in Percutaneous Nephrolithotomy (PCNL), How and Why?
Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our modification aims to decrease the complications of PCNL in large stones
Read the detailed description
Introduction : PCNL occupies the best stone management modality till now in large stones with promissing impacts as regard to morbidity and hospital stay time. (1,2,3) Many reported complications due to PCNL either intra or postoperative especially in large stones up to 83% including bleedng and extravasation .(4) Single step dilatation during PCNL track forminghave many advantages over sequential dilatation as it ismore economic with less blood loss and less radiation exposure, so it is advantageous than conventional Alken or teflon sequential dilators also it is more economic than balloon dilators. (5,6,7,8) To decrease the incidence bleeding, the manipulation should be limited and transpapillary puncture should be kept. (9) Extravasation remains one of the most serious complication during PCNL as vigorousabsorption of the irrigant fluid may cause electrolyte disbalance that may lead to cardiac complications (overload) or brain edema.. (10) Objective : Our modification aims to decrease the complications of PCNL in large stones.
Patients and methods : Our modification will be performed in our department in Benha univerisity hospital with a written consent on 10 patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/_ the upper calyx in patints 18 years old or more. Also, patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn stone will be excluded.
Preoperative assesment:
- full history and clinical examination
- full laboratory investigation including heamoglobin (Hb) and serum creatinine (Scr)
- radiological investigation as pelviabdomenal ultrasound , plain X ray (KUB) and coputerized tomography (CT)
Intraoperative assesment:
Under general anaesthesia, after ureteric catheter insertion and using fluoroscopic guidancein prone position introducing a superstiff guide wire targeting the posterior lower calyx transpapillary by puncture needle application then by a straight long artery beside the puncture needle advancing it till penetrating the fascia then open it in two different perpendicular planes to creat a wide tract permitting single step dilatation over the stiff guide wire then safety guide wire will be inserted .Using a long laparoscopic trocar 12mm (36 french) with central hole from its tip till its handle with transparent sheath also a side scrow included to adjust the irrigation fluid outflow and permitting using a suction system if stone disintegration performed while saline irrigation through the ureteric catheter was acting.
The superstiff wire will pass through the tip hole of the trocar ,then under C arm imaging the trocar directed to the targeted calx transpapillary not reaching the calyceal neck then nephroscopy and pneumatic lithotripsy used and then large fragments will be extracted and may reaches 1.5 to 2 cm.
Till the procedure end ,intraoperative time and the need for blood transfusion will be recorded.
Nephrotomy tube 28 f will be fixed in all cases.
Postoperative assessment:
Postoperative Hb , Scr KUB and CT if needed in the next morning will be performed, Also hospital stay and postoperative complications will be registered as fever , heamaturia and leakage from the nephrostoy tube site after its removal.
Keywords: single step dilatation, complications, partial staghorn stones, percutaneous nephrolithotomy Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
References :
- Geraghty J.P. and Somani B.K. (2017): Worldwide Trends of urinary stone disease treatment over the last two decades: a systematic review. J Endourol.; 31(6):547-556.
- Jones P., Elmussareh M., Aboumarzouk O. M., Mucksavage P. and Somani B. K.(2018): Role of Minimally Invasive (Micro and Ultra-mini) PCNL for Adult Urinary Stone Disease in the Modern Era: Evidence from a Systematic Review. Current Urology Reports 19: 27.
- Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M,Drake T ,Donaldson JF ,and Rubayel L (2019): EAU guideline on urolithiasis. [Accessed 2 July 2019]
- Michel MS, Trojan L,and Rassweiler JJ(2007): Complications in Percutaneous Nephrolithotomy in European urology.; 51(4)899-906.
- El-Shazly M, Salem S, Allam A, Hathout B. Balloon dilator versus telescopic metal dilators for tract dilatation during percutaneous nephrolithotomy for staghorn stones and calyceal stones. Arab J Urol 2015;13:80-3.
- Nour HH, Kamal AM, Zayed AS, Refaat H, Badawy MH, El-Leithy TR, et al. Single-step renal dilatation in percutaneous nephrolithotomy: A prospective randomised study. Arab J Urol 2014;12:219-22.
- Suelozgen T, Isoglu CS, Turk H, Yoldas M, Karabicak M, Ergani B, et al. Can we use single-step dilation as a safe alternative dilation method in percutaneous nephrolithotomy? Urology 2017;99:38-41.
- Desai MR, Sharma R, Mishra S, Sabnis RB, Stief C, Bader M, et al. Single-step percutaneous nephrolithotomy (microperc): The initial clinical report. J Urol 2011;186:140-5.
- Akman T, Binbay M, Sari E, Yuruk E, Tepeler A, Akcay M,Muslumanoglu AY and Tefekli.A (2011). Factors affecting bleeding during percutaneousnephrolithotomy: single surgeon experience. J Endourol; 25:327e33
- Taylor E, Miller J, Chi T,and Stoller ML (2012). Complications associated with percutaneous nephrolithotomy. Transl Androl Urol ; 1:223-228.
- Conditions
- PCNL
- Being tested
- laparoscopic trocar 12mm
- Keywords
- complications, partial staghorn stones, PCNL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic trocar 12mmDevice
long laparoscopic trocar 12mm (36 french) with central hole from its tip till its handle with transparent sheath
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease the intraoperative complication
assessing the operative time in minutes
Measured: intraoperative
blood loss in the operative theatre
pre and postoperative haemoglobine in gram/dl
Measured: intraoperative
Secondary outcomes (1)
early postoperative impact and incidence of complication
fever, heamaturia and leakage from the nephrostomy site
Measured: withen 10 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start25 Jan 2023 (estimated)
- Primary completion7 Mar 2023 (estimated)
- Study completion17 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCNLStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- mohamed abdelzaher
- Responsible party
- Principal investigator, mohamed abdelrahman alhefnawy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640219
- Sponsor's protocol ID
- PCNL track
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benha Modification for Renal Track Creation in Percutaneous Nephrolithotomy (PCNL), How and Why?
- ClinicalTrials.gov ID
- NCT05640219
- Acronym / sponsor ID
- PCNL track
- Conditions
- PCNL
- Keywords
- complications, partial staghorn stones, PCNL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- mohamed abdelzaher
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 7 Mar 2023 (estimated)
- Study completion
- 17 Mar 2023 (estimated)
- First posted
- 7 Dec 2022 (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.
Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our modification aims to decrease the complications of PCNL in large stones
Detailed description
Introduction : PCNL occupies the best stone management modality till now in large stones with promissing impacts as regard to morbidity and hospital stay time. (1,2,3) Many reported complications due to PCNL either intra or postoperative especially in large stones up to 83% including bleedng and extravasation .(4) Single step dilatation during PCNL track forminghave many advantages over sequential dilatation as it ismore economic with less blood loss and less radiation exposure, so it is advantageous than conventional Alken or teflon sequential dilators also it is more economic than balloon dilators. (5,6,7,8) To decrease the incidence bleeding, the manipulation should be limited and transpapillary puncture should be kept. (9) Extravasation remains one of the most serious complication during PCNL as vigorousabsorption of the irrigant fluid may cause electrolyte disbalance that may lead to cardiac complications (overload) or brain edema.. (10) Objective : Our modification aims to decrease the complications of PCNL in large stones.
Patients and methods : Our modification will be performed in our department in Benha univerisity hospital with a written consent on 10 patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/_ the upper calyx in patints 18 years old or more. Also, patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn stone will be excluded.
Preoperative assesment:
- full history and clinical examination
- full laboratory investigation including heamoglobin (Hb) and serum creatinine (Scr)
- radiological investigation as pelviabdomenal ultrasound , plain X ray (KUB) and coputerized tomography (CT)
Intraoperative assesment:
Under general anaesthesia, after ureteric catheter insertion and using fluoroscopic guidancein prone position introducing a superstiff guide wire targeting the posterior lower calyx transpapillary by puncture needle application then by a straight long artery beside the puncture needle advancing it till penetrating the fascia then open it in two different perpendicular planes to creat a wide tract permitting single step dilatation over the stiff guide wire then safety guide wire will be inserted .Using a long laparoscopic trocar 12mm (36 french) with central hole from its tip till its handle with transparent sheath also a side scrow included to adjust the irrigation fluid outflow and permitting using a suction system if stone disintegration performed while saline irrigation through the ureteric catheter was acting.
The superstiff wire will pass through the tip hole of the trocar ,then under C arm imaging the trocar directed to the targeted calx transpapillary not reaching the calyceal neck then nephroscopy and pneumatic lithotripsy used and then large fragments will be extracted and may reaches 1.5 to 2 cm.
Till the procedure end ,intraoperative time and the need for blood transfusion will be recorded.
Nephrotomy tube 28 f will be fixed in all cases.
Postoperative assessment:
Postoperative Hb , Scr KUB and CT if needed in the next morning will be performed, Also hospital stay and postoperative complications will be registered as fever , heamaturia and leakage from the nephrostoy tube site after its removal.
Keywords: single step dilatation, complications, partial staghorn stones, percutaneous nephrolithotomy Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
References :
- Geraghty J.P. and Somani B.K. (2017): Worldwide Trends of urinary stone disease treatment over the last two decades: a systematic review. J Endourol.; 31(6):547-556.
- Jones P., Elmussareh M., Aboumarzouk O. M., Mucksavage P. and Somani B. K.(2018): Role of Minimally Invasive (Micro and Ultra-mini) PCNL for Adult Urinary Stone Disease in the Modern Era: Evidence from a Systematic Review. Current Urology Reports 19: 27.
- Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M,Drake T ,Donaldson JF ,and Rubayel L (2019): EAU guideline on urolithiasis. [Accessed 2 July 2019]
- Michel MS, Trojan L,and Rassweiler JJ(2007): Complications in Percutaneous Nephrolithotomy in European urology.; 51(4)899-906.
- El-Shazly M, Salem S, Allam A, Hathout B. Balloon dilator versus telescopic metal dilators for tract dilatation during percutaneous nephrolithotomy for staghorn stones and calyceal stones. Arab J Urol 2015;13:80-3.
- Nour HH, Kamal AM, Zayed AS, Refaat H, Badawy MH, El-Leithy TR, et al. Single-step renal dilatation in percutaneous nephrolithotomy: A prospective randomised study. Arab J Urol 2014;12:219-22.
- Suelozgen T, Isoglu CS, Turk H, Yoldas M, Karabicak M, Ergani B, et al. Can we use single-step dilation as a safe alternative dilation method in percutaneous nephrolithotomy? Urology 2017;99:38-41.
- Desai MR, Sharma R, Mishra S, Sabnis RB, Stief C, Bader M, et al. Single-step percutaneous nephrolithotomy (microperc): The initial clinical report. J Urol 2011;186:140-5.
- Akman T, Binbay M, Sari E, Yuruk E, Tepeler A, Akcay M,Muslumanoglu AY and Tefekli.A (2011). Factors affecting bleeding during percutaneousnephrolithotomy: single surgeon experience. J Endourol; 25:327e33
- Taylor E, Miller J, Chi T,and Stoller ML (2012). Complications associated with percutaneous nephrolithotomy. Transl Androl Urol ; 1:223-228.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/ the upper calyx in patints 18 years old or more
Key exclusion criteria (1 listed)
- patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn
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 |
|---|---|---|
| laparoscopic trocar 12mmlong laparoscopic trocar 12mm (36 french) with central hole from its tip till its handle with transparent sheath | Device | – |
Primary outcome
decrease the intraoperative complication
Time frame: intraoperative
assessing the operative time in minutes
blood loss in the operative theatre
Time frame: intraoperative
pre and postoperative haemoglobine in gram/dl
1 secondary outcome
early postoperative impact and incidence of complication
Time frame: withen 10 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic trocar 12mm in people with PCNL, run by Benha University.
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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
decrease the intraoperative complication (time frame: intraoperative). 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?
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 25 Jan 2023.