Ureteral Access Sheath or Percutaneous Nephrostomy During Flexible Ureteroscopy: Which is Better?

NCT05633030 | Unknown

• 1 other identifier: Ureteral access sheath or PCN
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

we aim to compare the safety and efficacy of flexible ureteroscopy with ureteral access sheath (group A) in comparison with flexible ureteroscopy without UAS but with PCN insertion (group B) either intra or post operaively by recording all data and the benefits , also comparing the drawbacks on each group

Conditions

Flexible Ureteroscopy

Keywords

ureteral access sheath; ultrasound guided PCN

Outcome Measures

Primary Outcomes (1)

• intra-operative complications

  Operative time, intra-operative complications (bleeding, perforation, incompletion of procedure) and hospitalization periods

  3 mothes

Study Arms (2)

operated using UAS during flexible ureteroscopy

ACTIVE COMPARATOR

Procedure: using UAS during flexible ureteroscopy and using PCN during flexible ureteroscopy

operated using PCN during flexible ureteroscopy

ACTIVE COMPARATOR

Procedure: using UAS during flexible ureteroscopy and using PCN during flexible ureteroscopy

Interventions

using UAS during flexible ureteroscopy and using PCN during flexible ureteroscopy PROCEDURE

under general anesthesia and given appropriate antibiotic cover. a clssic flexible ureteroscopy procedure is done and appropriately sized UAS was then inserted over the wire and positioned just distal to the PUJ or below upper ureteric stone under fluoroscopic guidance. We then perform a flexible ureteroscopy using Olympus URF-V2 (8.5 Fr) flexible ureteroscope to inspect the proximal ureter if there is upper ureteric stone, renal pelvis, and calyces for the presence of stones. Irrigation with 0.9% saline solution via a pressure-infusing system. Next, Holmium laser lithotripsy with a holmium:YAG laser \[20 W; Lumenis (UK) Ltd., Elstree, UK\] using a 272 micron laser fiber (Lumenis, Inc.) is carried out and/or stone extraction with a basket device, in the other group we add inserted trans papillary in the lower calyx of the kidney by an expert intervention radiologist

operated using PCN during flexible ureteroscopy; operated using UAS during flexible ureteroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with upper ureteric stones and mild hydronephrosis or renal pelvic stones less than 20 mm with mild hydronephrosis

You may not qualify if:

• patients with active urinary tract infection and patients with uncontrolled coagulable status

Sponsors & Collaborators

• Benha University: lead

Central Study Contacts

mohamed abdrahman alhefnawy, assistant professor

CONTACT

00201003481084; dr.mohamedalhefnawy@gmail.com

hosam abdelfatah aboelnasr, lecturer

CONTACT

00201286296939; hosamabuelnasr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Group A: 50 patients will be operated using UAS during flexible ureteroscopy. Group B: 50 patients will be operated using PCN during flexible ureteroscopy.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11