Effect of Renal Access Sheath on Functions

NCT05232188 | Unknown

• 1 other identifier: NoyanOzluPCNL
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be randomly divided into two groups in order to evaluate the effect of the size of the access sheath (Amplatz) used in the Percutaneous Nephrolithotomy (PCNL) operation on kidney functions. After dilatation, 22French (Fr) Amplatz sheath will be placed in the first group, while 28Fr Amplatz sheath will be placed in the second group. The functional difference will be evaluated with preoperative and postoperative 3rd-month kidney scintigraphies (diethylenetriamine pentaacetic acid (DTPA) and technetium-99m dimercaptosuccinic acid (DMSA). In addition, Kidney Injury Molecule-1 (KIM-1) levels will be measured in the urine in order to be a predictor of functional loss in the early period.

Conditions

Kidney Function Tests; Treatment Outcome

Keywords

Percutaneous nephrolithotomy; Amplatz sheath

Outcome Measures

Primary Outcomes (3)

• Differential function changes

  Differential function changes in the operated kidney in postoperative DMSA and DTPA

  3 months

• Newly developed scar

  Presence of newly developed scar in DMSA

  3 months

• KIM-1

  Change in urinary KIM-1 levels

  24 hours

Secondary Outcomes (4)

• Creatinine

  24 hours

• Glomerular filtration rate

  24 hours

• Stone-free rate

  24 hours

• Complications

  30 days

Study Arms (2)

22French (Fr)

EXPERIMENTAL

After renal access, dilatation is provided up to 22Fr with a dilatator set, and fragmentation is started with a 19Fr nephroscope.

Procedure: Percutaneous nephrolithotomy

28F

EXPERIMENTAL

After renal access, dilatation is provided up to 28Fr with a dilatator set, and fragmentation is started with a 25Fr nephroscope.

Procedure: Percutaneous nephrolithotomy

Interventions

Percutaneous nephrolithotomy PROCEDURE

percutaneous nephrolithotomy surgery, 22F amplatz sheath is used in one group, while 28F amplatz sheath is used in the other group.

22French (Fr); 28F

Eligibility Criteria

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

You may qualify if:

• Patients with 2-3 cm kidney stones
• Patients with an American Society of Anesthesiologists ≤2 score
• BMI: Patients between 20 and 35 kg/m2

You may not qualify if:

• Patients with preoperative renal failure
• Patients with multiple access
• Patients undergone renal transplantation
• Patients with renal anomalies (horseshoe kidney, solitary kidney, double collecting system, etc.)
• Patients with history of open kidney stones surgery and/or PCNL history
• Patients who cannot be stone-free in the postoperative period (fragments \>4 mm in imaging) and require additional treatment intervention
• Patients with bleeding disorders
• Pregnant patients
• Patients with complete staghorn stones
• Patients with bilateral obstructive stones
• Patients with active infection

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Nephrolithotomy, Percutaneous

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: February 9, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

TU (1)