Standard PCNL Vs Endoscopic Combined Intrarenal Surgery (ECIRS) for Complex Nephrolithiasis in Obese Patients (ECIRS)

October 10, 2023 updated by: Moataz bellah Mohamed, Ain Shams University

Comparative Study Between Standard PCNL and Endoscopic Combined Intrarenal Surgery (ECIRS) in the Galdakaomodified Supine Valdivia (GMSV) Position for Complex Nephrolithiasis in Obese Patients

Primary aim: comparing the efficacy of standard PCNL and endoscopic combined intrarenal surgery (ECIRS) in the Galdakao-modified Supine Valdivia (GMSV) position in a single session for the treatment of complex nephrolithiasis in obese patients.

Secondary aim: comparing safety and complications of standard PCNL and ECIRS in the GMSV.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Complex nephrolithiasis including multiple peripheral or branched (partial or complete staghorn calculi) renal stones, is still currently an intractable problem for urologists to achieve stone-free status and minimize complication rates. According to the European Association of Urology Urolithiasis Guidelines, retrograde intrarenal surgery (RIRS) is recommended as first-line treatment for renal stones < 2 cm, and percutaneous nephrolithotomy (PCNL) is recommended as the gold standard for renal stones ≥ 2 cm in length.

Obesity has been identified as an independent risk factor for stone formation in the United States. Obesity (BMI >35) also places surgical patients at a greater risk of complications, because of the increased incidence in this group of diabetes, hypertension, ischemic heart disease, postoperative deep venous thrombosis, and pulmonary embolism, and because of poor radiographic visualization, obscure anatomic landmarks, more difficult renal access, and inferior stone-free rates.

Standard percutaneous nephrolithotomy (PCNL) is the recommended treatment by major guidelines. However, multiple tracts or sessions of PCNL were required to obtain a high stone-free rate (SFR) for complex renal calculi, especially staghorn stones, while procedure-related complications increased concomitantly. To acquire a higher SFR, full access to the entire intrarenal collecting system is the final goal of treatment for these patients suffering from multiple calyceal or peripheral satellite calculi, which is technically challenging by means of RIRS or PCNL monotherapy.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11361
        • Recruiting
        • Ain shams university hospitals
        • Contact:
          • Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Partial or complete staghorn stones)
  • Guy's Stone Score III or IV)
  • Adult (18-60) years old patients
  • Obese & super-obese patients (BMI > 30 kg/m 2).

Exclusion Criteria:

  • Patients with congenital renal anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous nephrolithotomy
the standard-PCNL group (will be performed by urologists with more than 2 years of experience of PCNL), Fluoroscopic-guided percutaneous renal access will be done for patients in the prone position.
Procedure: Percutaneous nephrolithotomy
Clearance of renal stone with nephroscope in prone position
Other Names:
  • PCNL
Active Comparator: Endoscopic combined intrarenal surgery
the ECIRS group (will be performed by urologists with more than 2 years of experience of PCNL and RIRS), patients will be oriented in the GMSV position.flexible ureteroscope will be inserted through the access sheath to observe the stone distributions. Under the guidance of fluoroscopy and endoscopic vision, a 18-20 Fr percutaneous tract will be established using sequential fascial dilators and a matching sheath for stone manipulation simultaneously. We use a 12-F nephroscope (Karl Storz).
Procedure: Endoscopic combined intrarenal surgery
Combined complex stone clearance with mini-nephroscope and flexible URS
Other Names:
  • ECIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of PCNL vs ECIRS
Time Frame: 2 days
Operative duration in minutes (from positioning to the end of the procedure) will be recorded for the two groups Stone-free status will be evaluated with a plain abdominal radiograph of the kidneys, ureters, and bladder (KUB) for radiopaque stones and NCCT for lucent stones before hospital discharge. Stone-free status is defined as no or small calyceal residuals of ≤ 4 mm (clinically insignificant residual fragment) without infection.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and complication of PCNL Vs ECIRS
Time Frame: 1 month.
Intraoperative complications will be recorded and 30-day postoperative complications will be graded according to the modified Clavien classification.
1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECIRS complex stones in obese

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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