NCT07310966

Brief Summary

Retrograde intrarenal surgery (RIRS) is an established minimally invasive treatment for renal stones, particularly for lower calyceal stones less than 2 cm, offering acceptable stone-free rates with low morbidity. However, stone clearance in the lower calyx remains technically challenging due to unfavorable anatomy, limited scope deflection, and gravity-dependent fragment retention. Patient positioning during RIRS has been suggested as a modifiable factor that may influence endoscopic access, stone relocation, and surgical ergonomics. The lithotomy position is conventionally used during RIRS, while the lateral position has been proposed to facilitate stone migration and improve lower calyceal access through gravitational assistance. Existing studies comparing patient positioning during RIRS are limited, with most evidence derived from retrospective analyses or non-randomized designs. Therefore, this randomized controlled trial aims to compare lithotomy versus lateral positioning during RIRS for lower calyceal stones less than 2 cm in terms of operative and clinical outcomes.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 16, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

lithotomy positionlateral positionlower calyxFURSRIRS

Outcome Measures

Primary Outcomes (1)

  • Stone Free Rate

    Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no

    1 month

Secondary Outcomes (2)

  • Operative time

    The operative time

  • Complications

    1 month

Study Arms (2)

Lithotomy position group

ACTIVE COMPARATOR

patients of this group undergo RIRS in Lithotomy position

Procedure: Lithotomy Position

Lateral position group

ACTIVE COMPARATOR

patients of this group undergo RIRS in lateral position

Procedure: Lateral position

Interventions

Patients undergo RIRS in lateral position

Lateral position group

Patients undergo RIRS in lithotomy position

Lithotomy position group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥18 years.
  • Single or multiple lower calyceal renal stones with stone size \<2 cm confirmed by NCCT.
  • Negative urine culture.
  • Presented cases.

You may not qualify if:

  • Multiple stones involving renal pelvis or other calyces.
  • Anatomical anomalies affecting ureteroscope access (horseshoe kidney, malrotation, ureteral strictures).
  • Pregnancy.
  • Prior ipsilateral renal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations