Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position for Percutaneous Nephrolithotomy (PCNL)

October 1, 2024 updated by: Hesham Abdel Azim El Helaly, Fayoum University Hospital
Comparing Efficacy and Complication Between Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

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 Locations

  • Egypt
      • Fayoum, Egypt, 4558
        • Fayoum faculty of Medicine

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Staghorn calculi
  2. Renal pelvis stones >2 cm
  3. Lower pole stones >1.5 cm
  4. SWL-resistant stones

Exclusion Criteria:

  1. Age <18 years or Pregnancy
  2. Bilateral simultaneous PCNL
  3. Need for 3 percutaneous tracts intraoperative
  4. Morbid obesity (BMI >40)
  5. Non opaque renal stones.
  6. Refuse to complete study requirements
  7. Atypical bowel interposition need CT guided puncture
  8. Tumour in the presumptive access tract area or Potential malignant kidney tumour

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: prone PNL
Prone PNL
Procedure: Prone PNL
Prone PNL
Active Comparator: prone-flexed PNL
Procedure: Prone-flexed PNL
Prone-flexed PNL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the prone with the prone-flexed position for PCNL reporting complications
Time Frame: 1 year
Outcome measures by using the clavien dindo classification system
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of stone free rate of the two groups
Time Frame: 1 year
Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT)
1 year

Collaborators and Investigators

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

Sponsor

Fayoum University Hospital

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)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF-PCNL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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