Endoscopic Guided PCNL Versus Standard PCNL

NCT ID: NCT04825353

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-20

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.

patients \& methods: Patients will randomly be divided into two equal groups:

Group A: Patient will undergo ECIRS.

Group B: Patient will undergo standard PCNL

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stones, Kidney

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ECIRS-Group

Group Type EXPERIMENTAL

Endoscopic compbined guided PCNL

Intervention Type PROCEDURE

patient undergo stone removal by ECIRS

SPCNL-GRoup

Group Type ACTIVE_COMPARATOR

Standard PCNL

Intervention Type PROCEDURE

patient undergo SPCNL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic compbined guided PCNL

patient undergo stone removal by ECIRS

Intervention Type PROCEDURE

Standard PCNL

patient undergo SPCNL

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* patients with renal anomalies.
* transplanted kidney.
* uncorrected coagulopathy.
* active infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Benha University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Waleed El-Shaer, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banha university hospital

Banhā, Qalyubia Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Waleed El-Shaer, M.D

Role: CONTACT

01015767331 ext. 0020

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IDIRB2017122601-268

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

High Supracostal Versus Subcostal Puncture in Adult PCNL
NCT06350045 ACTIVE_NOT_RECRUITING PHASE4