None listed
Conditions
Brief summary
LAY SUMMARY Mini-percutanoeus nephrolithotomy (mini-PCNL) and flexible ureteropyeloscopy are commonly used techniques for treating ureteral and renal stones. Both treatment options are invasive and are associated with complications. There are only a few studies that compare these two treatment modalities. Both modalities are associated with reasonable postoperative stone free rates with minimal complications. Immediate stone free rate is higher with mini-PCNL but comparable in both modalities at 1 month. Pyeloscopy is associated with favourable pain scores and lower haemoglobin drop. We aim to compare both techniques to definitively investigate whether one modality is superior than the other. HYPOTHESIS Few prospective randomised controlled trials have compared mini-PCNL and flexible ureteropyeloscopy for treating renal and proximal ureteral stones.Furthermore, no specific guideline is available regarding the optimal surgical management of renal stones and proximal ureteral stones. We hypothesise that one modality is associated with a greater stone free rate and lower complication rate compared to the other modality for managing nephrolithiasis STUDY AIMS: To compare stone free rate and surgical parameters between flexible ureteropyeloscopy mini-PCNL and RIRS in the management of renal stones and proximal ureteral stones >5 mm in a single session. OUTCOME MEASURES The primary end-point in this study is stone free rate (SFR) in a single session. Before a 3-month follow-up visit, all patients will undergo a low-dose non-contrast CT scan to assess for the presence of residual stone. Stone free status is defined as no residual stones or stones within 3 months postoperatively. The secondary outcomes are intraoperative and postoperative parameters such as operation time, hemoglobin drop, analgesic requirement, hospital stay, and complications. Complications will be evaluated according to the Clavien classification of surgical complications. We have published a systematic review and meta-analysis as part of the background information and research to this randomized controlled trial and have attached it to our application: World J Urol. 2018 Feb 16. doi: 10.1007/s00345-018-2230-x. MINIATURISED PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROPYELOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS COMPARING CLINICAL EFFICACY AND SAFETY PROFILE. Davis NF1, Quinlan MR2, Poyet C2, Lawrentschuk N2, Bolton DM2, Webb D2, Jack GS2. Our systematic review and meta-analysis provides a detailed and accurate comparative analysis on mini-PCNL and FURS. We found that modifications and advancements in equipment design will continue to improve the performance of both techniques. The continuing evolution of both urological technologies, should facilitate high levels clinical efficacy while maintaining high safety profiles.
Interventions
Description of intervention:
The intervention involves urinary tract calculi removal by one of two techniques that are described in detail below.
1. mini-PCNL
The patient is initially placed in lithotomy position under general or epidural anaesthesia and a 5 French ureteral catheter is placed up to the renal pelvis or onto the stone. The patient is then turned prone and a 19 gauge puncture needle is placed into the appropriate calyx under fluoroscopic guidance. A guidewire is inserted and fixed
Description of intervention: The intervention involves urinary tract calculi removal by one of two techniques that are described in detail below. 1. mini-PCNL The patient is initially placed in lithotomy position under general or epidural anaesthesia and a 5 French ureteral catheter is placed up to the renal pelvis or onto the stone. The patient is then turned prone and a 19 gauge puncture needle is placed into the appropriate calyx under fluoroscopic guidance. A guidewire is inserted and fixed. and the puncture needle is then removed. After a 0.5–0.7 cm skin incision, dilation of the percutaneous tract is performed serially over the guidewire with a fascial dilator to 16–22 Fr.ench. A 12 French nephroscope is inserted into the kidney, and the holmium laser is applied for stone disintegration. Fragments are taken out by flushing or forceps. At the end of the surgery, a nephrotomy tube and a double J stent is placed at the surgeon's discretion. The stent is removed at 1 month using cystoscopy. 2. Flexible ureteropyeloscopy The procedures are performed under general or epidural anaesthesia with the patient in lithotomy position. In some cases, a 6 French stent is placed 1 or 2 weeks before the procedure as a temporary measure to relieve acute obstruction from stones, infection, or uncontrolled pain due to stones; or to dilate the ureter of patients who have experienced unsuccessful insertion of ureteroscope before. If so, rigid ureteroscopy is performed to remove the pre-placed stent. Then a hydrophilic guidewire is placed to direct the placing of a ureteral access sheathmeasuring 12-14 French. Then the flexible ureteroscope is advanced through the sheath. The stones are fragmented with a holmium laser until debris below 4 mm is achieved. Fragments are removed with a basket as many as possible. A double-J stent is placed at the end of the procedure routinely and is removed at 1 month postoperatively. Frequency and duration of procedure: Both interventions aim to fully clear the stone in a single session. Both procedures typically take 60 to 90 minutes to complete. Who will be administering the intervention: Both interventions are performed by a consultant urologist. Dr Niall Davis will follow-up all patients that are recruited to monitor fidelity and objectively gather information on primary and secondary outcome variables.
Sponsors
Mr Greg Jack
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
RECRUITMENT PROCEDURE Eligible patients are consecutive patients who presented to the urology outpatient department with a proximal ureteric and/ or greater than 1 intrarenal calculus that is greater than 0.5cm requiring intervention due to symptoms such as pain or recurrent urinary tract infections., and in whom flexible ureteropyeloscopy or mini-PCNL is planned. INCLUSION CRITERIA Eligible patients are patients with proximal ureteral or intra-renal stones greater than 0.5 cm in size referred to our institute will be considered for this study. The proximal ureter is defined as the portion extending from the ureteropelvic junction to the lower border of the fourth lumbar vertebra.
Exclusion criteria
EXCLUSION CRITERIA Patients with urogenital anomaly, solitary kidney, age <18 years, age >75 years or coagulopathy will be excluded.
Outcome results
None listed