Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi

NCT ID: NCT06519812

Last Updated: 2024-07-25

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-06-30

Brief Summary

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This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety

Detailed Description

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This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.

Conditions

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Urinary Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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• Group I (PCNL group)

50 patients will undergo percutaneous nephrolithotomy (PCNL).

Group Type EXPERIMENTAL

Combined Intrarenal Surgery and percutaneous nephrolithotomy

Intervention Type PROCEDURE

A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.

Group II (ECIRS group)

50 patients will undergo endoscopic combined intrarenal surgery (ECIRS).

Group Type EXPERIMENTAL

Combined Intrarenal Surgery and percutaneous nephrolithotomy

Intervention Type PROCEDURE

A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.

Interventions

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Combined Intrarenal Surgery and percutaneous nephrolithotomy

A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients are more than 18 and less than 65 years old.
* Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).

Exclusion Criteria

* Patients with renal insufficiency (serum creatinine \> 1.6 mg/dl)
* patients with active urinary tract infection.
* Patients with congenital renal anomalies.
* Morbid obesity (BMI \> 35 kg/m2).
* Pregnancy.
* Bleeding Coagulopathy.
* Skeletal deformity
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Maher Mohamed Abdelrehem Mohamed

Assistant Lecturer of Urology Faculty of Medicine, Al-Azhar University (Damietta)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maher Abdelrehem Mohamed, Master

Role: PRINCIPAL_INVESTIGATOR

assistant lecturer of urology , Al-Azhar University (Damietta)

Locations

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Al-Azhar University Hospital (New Damietta)

Damietta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maher Abdelrehem Mohamed, Master

Role: CONTACT

01026816086 ext. 020

Facility Contacts

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Mohamed shenishan, master

Role: primary

01152370018 ext. 020

Other Identifiers

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Urosurg./MD/2023/0008

Identifier Type: -

Identifier Source: org_study_id

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