Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05855057
Collaborator
(none)
123
1
48
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Flank suspended supine position percutaneous nephrolithotomy
  • Procedure: Supine percutaneous nephrolithotomy group
  • Procedure: Prone percutaneous nephrolithotomy group

Detailed Description

Percutaneous nephrolithotomy (PCNL) has become the choice of modality for the treatment of large and complicated renal calculi. Initially, percutaneous access to the kidney was only performed in the prone position, as described sixty years ago.

Study Design

Study Type:
Observational
Actual Enrollment :
123 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Single Centered Cohort Study Comparing The Effectiveness of Ultrasound-Guided PCNL Different Positions in Renal Stones Treatment
Actual Study Start Date :
Jan 20, 2018
Actual Primary Completion Date :
Jan 20, 2022
Actual Study Completion Date :
Jan 20, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

Supine percutaneous nephrolithotomy group

This group included 41 patients in supine percutaneous nephrolithotomy.

Procedure: Supine percutaneous nephrolithotomy group
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°.

Prone percutaneous nephrolithotomy group

This group included 41 patients in prone percutaneous nephrolithotomy.

Procedure: Prone 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.

Outcome Measures

Primary Outcome Measures

  1. Stone clearance rate [3 months postoperatively]

    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.

Secondary Outcome Measures

  1. Operative time [Intraoperatively]

    duration of the Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) procedure among different positions

  2. Complication rates [48 hours Postoperatively]

    Comparison of postoperative complications (e.g., bleeding, infection, injury) among the different positions.

  3. Stone-free rates [48 hours Postoperatively]

    Comparison of the percentage of patients achieving complete stone clearance among the different positions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Patient refusal.

  • Pregnant women.

  • Patients with renal anomalies.

  • Transplanted kidney.

  • Uncorrected coagulopathy, or active infection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Benha University Hospitals Benha Egypt

Sponsors and Collaborators

  • Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abou Elezz Abdel Fattah, Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt, Benha University
ClinicalTrials.gov Identifier:
NCT05855057
Other Study ID Numbers:
  • RC 14-4-2023
First Posted:
May 11, 2023
Last Update Posted:
May 11, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2023