SUFLEX study : Suction-Enhanced PCNL versus Flexible Endoscopy with Suction Assistance for Lower Pole Stones

Suction enhanced percutaneous nephrolithotomy(PCNL) versus flexible and navigable suction sheath(FANS) –Assisted retrograde intrarenal surgery( RIRS) for management of lower pole renal stones: A prospective Randomized study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202510474240715

Enrollment

100

Registered

2025-10-22

Start date

2025-11-15

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Urological and Genital Diseases

Interventions

Suction enanced mini PCNL

Flexible and Navigable Suction Sheath Assisted Retrograde Intrarenal Surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults 2. Single lower-pole renal stone = 20 mm (on NCCT). 3. Normal renal anatomy and unobstructed pelvicalyceal system. 4. Unilateral stones with preserved renal function. 5. Medically fit for general anesthesia. 6. Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Stones > 20 mm, staghorn or multiple calyceal stones. 2. Abnormal renal anatomy (horseshoe, duplex, malrotated kidney, PUJ obstruction, diverticulum). 3. Concomitant ureteric stones or ureteral pathology. 4. Active urinary tract infection or untreated bacteriuria. 5. Bleeding diathesis or anticoagulant use not correctable. 6. Pregnancy. 7. Severe comorbidities precluding anesthesia. 8. Previous renal surgery on the same side. 9. Solitary kidney, CKD patients or inability to complete follow-up.

Design outcomes

Primary

Measure	Time frame
Stone-Free Rate (SFR) at 1 month, CT-confirmed (NCCT =2 mm fragments counted as residual; i.e., SFR = no fragments >2 mm).	—

Secondary

Measure	Time frame
• Operative time (skin incision/endoscope-in to final scope out or nephrostomy/stent placement; minutes). • Complications within 30 days, Clavien–Dindo graded; also report fever =38.5 °C, urosepsis, transfusion. • Fluoroscopy time (seconds) and radiation dose (mGy·cm² if available). • Post-op stenting (yes/no; dwell time). • Length of stay (days). • Retreatment/auxiliary procedures within 3 months. • Post-op pain (NRS at 6–12–24 h) and analgesic consumption (morphine-equivalents). • Hemoglobin drop (g/dL) and creatinine change (mg/dL).	—

Measure

Time frame

• Operative time (skin incision/endoscope-in to final scope out or nephrostomy/stent placement; minutes). • Complications within 30 days, Clavien–Dindo graded; also report fever =38.5 °C, urosepsis, transfusion. • Fluoroscopy time (seconds) and radiation dose (mGy·cm² if available). • Post-op stenting (yes/no; dwell time). • Length of stay (days). • Retreatment/auxiliary procedures within 3 months. • Post-op pain (NRS at 6–12–24 h) and analgesic consumption (morphine-equivalents). • Hemoglobin drop (g/dL) and creatinine change (mg/dL).

—

Countries

Egypt

Contacts

Public ContactMohamed ElMaadawy

Lecturer and consultant of Urology

Mohamed.elmaadawy@med.tanta.edu.eg00201060245430

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026