NCT04825353

Brief Summary

currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm. the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

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

October 20, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

March 25, 2021

Last Update Submit

July 17, 2022

Conditions

Stones, Kidney

Outcome Measures

Primary Outcomes (3)

  • Stone Free Rate

    If their is any residual stones

    1day after operation.

  • Stone Free Rate

    If their is any residual stones

    1 months post operative

  • Stone Free Rate

    If their is any residual stones

    3 months post-operative

Secondary Outcomes (2)

  • operative time

    intra oprative

  • blood loss

    pre-operative and 1 day post-oprative

Study Arms (2)

ECIRS-Group

EXPERIMENTAL
Procedure: Endoscopic compbined guided PCNL

SPCNL-GRoup

ACTIVE COMPARATOR
Procedure: Standard PCNL

Interventions

Endoscopic compbined guided PCNLPROCEDURE

patient undergo stone removal by ECIRS

ECIRS-Group
Standard PCNLPROCEDURE

patient undergo SPCNL

SPCNL-GRoup

Eligibility Criteria

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

You may qualify if:

  • patients with renal stones diameter of at least 2 cm.
  • American Society of Anesthesiology score ≤ 2.

You may not qualify if:

  • patients with renal anomalies.
  • transplanted kidney.
  • uncorrected coagulopathy.
  • active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha university hospital

Banhā, Qalyubia Governorate, 13511, Egypt

RECRUITING

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

Waleed El-Shaer, M.D

CONTACT

01015767331waleed_elshaer@hotmail.com

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
Associate professor

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 1, 2021

Study Start

October 20, 2019

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

EG(1)