NCT05855057

Brief Summary

The aim of this study is to compare the effectiveness of Ultrasound-Guided Percutaneous nephrolithotomyin different positions supine, prone positions and flank suspend supine position in renal stones treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

May 3, 2023

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stone clearance rate

    Comparison of stone clearance rates among different positions (flank suspended supine, supine, and prone) in Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) for the treatment of renal stones.

    3 months postoperatively

Secondary Outcomes (3)

  • Operative time

    Intraoperatively

  • Complication rates

    48 hours Postoperatively

  • Stone-free rates

    48 hours Postoperatively

Study Arms (3)

Flank suspended supine position percutaneous nephrolithotomy

This group included 41 patients in flank suspended supine position percutaneous nephrolithotomy.

Procedure: Flank suspended supine position percutaneous nephrolithotomy

Supine percutaneous nephrolithotomy group

This group included 41 patients in supine percutaneous nephrolithotomy.

Procedure: Supine percutaneous nephrolithotomy group

Prone percutaneous nephrolithotomy group

This group included 41 patients in prone percutaneous nephrolithotomy.

Procedure: Prone percutaneous nephrolithotomy group

Interventions

The patients will be placed in the supine position with the shoulder and the buttock will be raised by a 3-l bag of water suspending the flank of the affected side. The body contour will be aligned to the edge of the table. The operating table will be adjusted to the jack knife position, with the tip of the lower part of the table will be slightly lowered. The leg of the affected side of the patent will be straightened dorsally flexed and slightly inner rotated, with the knee of the other side will be flexed. The patients will be then immobilized at the chest and the pelvis with two adherent tapes which crossed each other at the abdomen to form a 'V' shape.

Flank suspended supine position percutaneous nephrolithotomy

The patient will remain in the supine position, with the side of interest at the edge of the table, with a small cushion placed under the flank to elevate it 15-20°.

Supine percutaneous nephrolithotomy group

Prone percutaneous nephrolithotomy. The prone position (PRON) technique followed these classic steps: patients will be placed in a lithotomy position and a ureteral catheter will be inserted through a rigid cystoscope to perform a retrograde pyelogram. The ureteral catheter will be fixed to a Foley catheter, and then the patient will be repositioned to the prone position with pads under their shoulders.

Prone percutaneous nephrolithotomy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

123 patients who underwent Percutaneous nephrolithotomy at the period from 2018 to 2022 and were diagnosed with consecutive, adult obese patients (age \>18-70 years) with renal stones diameter ≥2 cm

You may qualify if:

  • patients who underwent Percutaneous nephrolithotomy
  • Patient's age from \>18 - 70 years old.
  • Body mass index (30-40 kg/m2).
  • Both sex
  • Renal stones diameter ≥2 cm
  • Cardiac patients

You may not qualify if:

  • Patient refusal.
  • Pregnant women.
  • Patients with renal anomalies.
  • Transplanted kidney.
  • Uncorrected coagulopathy, or active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospitals

Banhā, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 11, 2023

Study Start

January 20, 2018

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

The study will be available under a reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL
Time Frame
One year after the end of the study.

Locations