NCT06624306

Brief Summary

Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

September 24, 2024

Last Update Submit

October 1, 2024

Conditions

UrolithiasisKidney StoneComplication

Outcome Measures

Primary Outcomes (1)

  • Comparing the prone with the prone-flexed position for PCNL reporting complications

    Outcome measures by using the clavien dindo classification system

    1 year

Secondary Outcomes (1)

  • Assessment of stone free rate of the two groups

    1 year

Study Arms (2)

prone PNL

ACTIVE COMPARATOR

Prone PNL

Procedure: Prone PNL

prone-flexed PNL

ACTIVE COMPARATOR

prone-flexed PNL

Procedure: Prone-flexed PNL

Interventions

Prone PNLPROCEDURE

Prone PNL

prone PNL
Prone-flexed PNLPROCEDURE

Prone-flexed PNL

prone-flexed PNL

Eligibility Criteria

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

You may qualify if:

  • Staghorn calculi
  • Renal pelvis stones \>2 cm
  • Lower pole stones \>1.5 cm
  • SWL-resistant stones

You may not qualify if:

  • Age \<18 years or Pregnancy
  • Bilateral simultaneous PCNL
  • Need for 3 percutaneous tracts intraoperative
  • Morbid obesity (BMI \>40)
  • Non opaque renal stones.
  • Refuse to complete study requirements
  • Atypical bowel interposition need CT guided puncture
  • Tumour in the presumptive access tract area or Potential malignant kidney tumour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum faculty of Medicine

Al Fayyum, Faiyum Governorate, 4558, Egypt

Location

MeSH Terms

Conditions

UrolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 24, 2024

First Posted

October 2, 2024

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 2, 2024

Record last verified: 2023-12

Locations

EG(1)