Supine Percutaneous Nephrolithotomy

NCT04869969 | Completed Phase 2 DMC

• 1 other identifier: R32/ 2019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• stone free rate

  evaluation of our patients after surgery with Xray or CT to detect residual stones

  first day postoperative

Secondary Outcomes (10)

• Fluoroscopy time during the procedure in minutes

  intraoperative finding in minutes,

• operative time of the procedure in minutes

  intraoperative finding in minutes,

• rate of Hemoglobin drop

  day 1 post operative

• hospital stay

  first 2 days post surgery

• incidence of urinary tract infection

  first 7 days post surgery

Study Arms (2)

supine percutaneous nephrolithotomy

EXPERIMENTAL

percutaneous nephrolithotomy to be done in the supine position

Procedure: percutaneous nephrolithotomy (supine position)

prone percutaneous nephrolithotomy

ACTIVE COMPARATOR

percutaneous nephrolithotomy to be done in the prone position

Procedure: percutaneous nephrolithotomy ( prone position)

Interventions

percutaneous nephrolithotomy (supine position) PROCEDURE

percutaneous nephrolithotomy to be done in the supine position

supine percutaneous nephrolithotomy

percutaneous nephrolithotomy ( prone position) PROCEDURE

percutaneous nephrolithotomy in the prone position

prone percutaneous nephrolithotomy

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy

You may not qualify if:

• patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention.
• patients with skeletal abnormalities and spine deformities were also excluded
• patients with a single kidney were also excluded

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospital

Cairo, 11367, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nephrolithotomy, Percutaneous; Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and the statistician were blinded to the type of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: percutaneous nephrolithotomy to be performed in both supine and prone position

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: May 3, 2021
• Study Start: June 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: September 30, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)