Supine Percutaneous Nephrolithotomy

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04869969
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Stone	Procedure: percutaneous nephrolithotomy (supine position); Procedure: percutaneous nephrolithotomy ( prone position)	Phase 2/Phase 3

Detailed Description

The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury.

Supine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position.

our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: percutaneous nephrolithotomy to be performed in both supine and prone positionpercutaneous nephrolithotomy to be performed in both supine and prone position
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: patients and the statistician were blinded to the type of the intervention
• Primary Purpose: Treatment
• Official Title: Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.
• Actual Study Start Date: Jun 1, 2019
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: supine percutaneous nephrolithotomy percutaneous nephrolithotomy to be done in the supine position	Procedure: percutaneous nephrolithotomy (supine position); percutaneous nephrolithotomy to be done in the supine position
Active Comparator: prone percutaneous nephrolithotomy percutaneous nephrolithotomy to be done in the prone position	Procedure: percutaneous nephrolithotomy ( prone position); percutaneous nephrolithotomy in the prone position

Outcome Measures

Primary Outcome Measures

1. stone free rate [first day postoperative]

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

Secondary Outcome Measures

1. Fluoroscopy time during the procedure in minutes [intraoperative finding in minutes,]

   time of fluoroscopy exposure in minutes intraoperative, time of radiational exposure during the surgery. operative finding only

2. operative time of the procedure in minutes [intraoperative finding in minutes,]

   time from patient positioning till the end of the procedure, operative finding only

3. rate of Hemoglobin drop [day 1 post operative]

   change in the perioperative hemoglobin level

4. hospital stay [first 2 days post surgery]

   days of hospital stay after the surgery

5. incidence of urinary tract infection [first 7 days post surgery]

   presence of manifested urinary tract infection in our patient

6. urine leakage [first 3 days postoperative]

   urine leakage from the percutaneous renal tract

7. irrigation fluid usage [intraoperative finding]

   amount of irrigation fluid used during the surgery in liters

8. postoperative fever [first 2 days post surgery]

   incidence of postoperative fever more than 38 c

9. need for DJ application [intraoperative finding]

   the need for DJ application intraoperative due to rough manipulation, bleeding or residual stones

10. incidence of intraoperative colonic injury [intraoperative finding]

    the accident injury to adjacent colon

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospital	Cairo		Egypt	11367

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Maher Gamil Ahmed Higazy, assistant lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04869969
• Other Study ID Numbers: R32/ 2019
• First Posted: May 3, 2021
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis

Study Results

No Results Posted as of Jul 14, 2022