NCT05379894

Brief Summary

perform a comparative randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions in management of complex renal stones

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2022Jun 2026

First Submitted

Initial submission to the registry

May 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

May 10, 2022

Last Update Submit

May 14, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position

    number of participants completely stone-free

    4 years

  • comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position

    measure amount of blood loss

    4 years

  • comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine position

    measure of Time of operation

    4 years

Study Arms (2)

group (1 ) Modified Supine

Modified Supine position PNL

Procedure: Percutaneous nephrolithotripsy

group (2) prone

Prone position PNL

Procedure: Percutaneous nephrolithotripsy

Interventions

Extraction of kidney stones through skin using nephroscope

Also known as: PNL
group (1 ) Modified Supinegroup (2) prone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients with renal stones candidate for operation

You may qualify if:

  • Grade II - A solitary stone in the upper pole with simple anatomy or multiple stones in a patient with simple anatomy or any solitary stone in a patient with abnormal anatomy
  • Grade III - Multiple stones in a patient with abnormal anatomy or, stones in a calyceal diverticulum or partial staghorn calculus
  • Grade IV - Staghorn calculus or any stone in a patient with spina bifida or spinal injury.

You may not qualify if:

  • · Pediatric group
  • Grade I - A solitary stone in the mid/lower pole with simple anatomy or a solitary stone in the pelvis with simple anatomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit facility of medicine

Asyut, Assuit, Egypt

RECRUITING

Related Publications (2)

  • Gokce MI, Ibis A, Sanci A, Akinci A, Bagci U, Agaoglu EA, Suer E, Gulpinar O. Comparison of supine and prone positions for percutaneous nephrolithotomy in treatment of staghorn stones. Urolithiasis. 2017 Dec;45(6):603-608. doi: 10.1007/s00240-017-0977-y. Epub 2017 Mar 29.

  • McCahy P, Rzetelski-West K, Gleeson J. Complete stone clearance using a modified supine position: initial experience and comparison with prone percutaneous nephrolithotomy. J Endourol. 2013 Jun;27(6):705-9. doi: 10.1089/end.2012.0650. Epub 2013 Mar 18.

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

Yasser Abdel salam

CONTACT

Ahmed Shehata El Azab

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 18, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations