NCT04345835

Brief Summary

prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 12, 2020

Last Update Submit

April 13, 2020

Conditions

Renal Stones

Outcome Measures

Primary Outcomes (1)

  • position complications

    Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system

    end of the study

Secondary Outcomes (4)

  • stone score system

    end of the study

  • stone characteristics

    end of the study

  • stone volume

    end of the study

  • hemostatic measures

    end of the study

Study Arms (2)

prone flexed

ACTIVE COMPARATOR

prone flexed PCNL position

Procedure: Percutanous nephrolithotomy (PCNL)

prone

ACTIVE COMPARATOR

prone position PCNL

Procedure: Percutanous nephrolithotomy (PCNL)

Interventions

Percutanous nephrolithotomy (PCNL)PROCEDURE

different procedure positioning

Also known as: PNL
proneprone flexed

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Large renal or upper ureteral calculi or both,

You may not qualify if:

  • (1) Age \<18 years or Pregnancy (2) Ureter pelvic junction obstruction (3) Bilateral simultaneous PCNL (4) Need for 3 percutaneous tracts intraoperative (5) Morbid obesity (BMI \>40) (6) Non opaque renal stones. (7)Refuse to complete study requirements (8)Untreated UTI (9)Atypical bowel interposition by CT (10)Tumour in the presumptive access tract area or Potential malignant kidney tumour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh faculty of medicine

Kafr ash Shaykh, Kafrelsheikh, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Diaa Eldin Taha, MD

    Lecturer of urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of urology

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 14, 2020

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)