PCNL Versus RIRS for Management of Stones in Solitary Kidney

NCT07730892 | Active Not Recruiting

• 1 other identifier: MD.24.09.899
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. The study aims to compare the safety and efficacy of the use of percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy in the treatment of renal stones \_ ≤ 3 cm in largest diameter through a prospective non randomized study in the period between August 2024 and August 2026. Stone-free rate will be assessed by NCCT done at 1st day postoperative and after 3 months. For Evaluation of kidney function postoperatively, creatinine clearance will be done after 1month and renal isotope scan will be done after 3 months. In addition, the results will be compared to the data of the patients with solitary kidney and renal stones who were retrospectively treated by PCNL or RIRS in the period between 2002 and 2024. The cases should fulfil the same inclusion criteria of the prospective study.

Conditions

Renal Stones

Outcome Measures

Primary Outcomes (1)

• stone free rate

  Stone-free status: it will be assessed by NCCT (defined as the absence of any stones or presence of only clinically insignificant residual stones \< 4 mm as measured by NCCT). Sub classified to * Initial stone free rate (1st day postoperative) * Final stone free rate (after 3 months)

  within 3 months after surgery

Secondary Outcomes (7)

• complication rate

  within 30 days after surgery

• number of sessions

  3 months after surgery

• renal function evaluation

  within 3 months after surgery

• auxiliary procedures

  within 3 months after surgery

• hospital stay

  from date of surgery until hospital discharge ( up to 30 days )

Study Arms (2)

RIRS

EXPERIMENTAL

patients undergo retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney

Procedure: retrograde intra renal surgery (RIRS)

PCNL

EXPERIMENTAL

patients undergo percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney

Procedure: percutaneous nephrolithotomy (PCNL)

Interventions

retrograde intra renal surgery (RIRS) PROCEDURE

standard retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney

RIRS

percutaneous nephrolithotomy (PCNL) PROCEDURE

standard percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney

PCNL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with anatomical or functional solitary kidney.
• Renal stones ≤ 3 cm in largest diameter- as measured by non-contrast spiral CT
• Age ≥ 18 years.

You may not qualify if:

• Patients who did not meet the above criteria.
• bleeding diathesis or those on anticoagulant therapy.
• concomitant pathology as ureteric stricture or renal congenital anomalies .

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology center , Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ahmed M. Shoma, Professor of urology

  Urology and Nephrology Center , Mansoura university , Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 28, 2026
• Study Start: November 23, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)