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A study to compare stone free rate using suction versus conventional ureteral access sheath in retrograde intrarenal surgery for nephrolithiasis

Comparative efficacy of suction versus conventional ureteral access sheath in achieving stone free status in retrograde intrarenal surgery: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071618
Enrollment
80
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Conventional ureteric access sheath (cUAS): i)Use of 10/12 Fr conventional ureteric access sheath (U-FLEX, allwin® Medical Devices) into the ureter till renal pelvis ii)7.5Fr digital fl
frequency 15-30Hz
12–16W iv)6Fr double-J stent (DEVON®, India) routinely placed Control Intervention1: Suction ureteric access sheath (sUAS): i)Use of 10/12Fr suction ureteral access sheath (V-UAS, ClearPetra®, Well Le
12–16W v)6Fr double-J stent (DEVON®, India) routinely placed

Sponsors

Dr Robal Lacoul
Lead Sponsor
Dr Pawan Raj Chalise
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All patients with symptomatic renal stones undergoing retrograde intrarenal surgery (RIRS) with renal stone less than 2cm in any location

Exclusion criteria

Exclusion criteria: i)Age less than 18yrs ii)Congenital anomalous kidney (Horseshoe kidney, Ectopic kidney, Crossed fused renal ectopia) iii)History of previous ureteric injury and ureteric reconstruction or known ureteric anomalies (Duplex collecting system) iv)Undergoing endoscopic combined intra renal surgery v)Need for conversion to PCNL intra-operatively vi)Bilateral same sitting RIRS vii)Previous ureteric injury or known ureteric anomalies or past ureteric reconstruction viii)Patients with known chronic renal failure on renal replacement therapy ix)Need to abandon surgery intra-operatively due to non-technical reasons

Design outcomes

Primary

MeasureTime frame
to compare stone free rate between use of conventional and suction ureteric access sheathTimepoint: 3 months

Secondary

MeasureTime frame
to compare complicationsTimepoint: 2 weeks;to compare need of re-interventionTimepoint: 1 month;to compare operative timeTimepoint: 1 day;to compare stone free statusTimepoint: 1 day

Countries

Nepal

Contacts

Public ContactDr Pawan Raj Chalise

Maharajgunj Medical Campus, Institute of Medicine

pawan_rc@yahoo.com9851067980

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026