Percutaneous Nephrolithotomy Without a Ureteral Catheter

NCT05598671 | Recruiting DMC

• 1 other identifier: nhfy0520
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional Percutaneous nephrolithotomy (PCNL) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. However, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the PCNL surgery.

Conditions

Nephrolithotomy Percutaneous; Kidney Calculi

Outcome Measures

Primary Outcomes (9)

• Rate of fever

  Fever was defined as axillary temperature greater than 38.5 ° C.

  From the day of surgery to the day of discharge, up to 2 weeks.

• White blood cell count change value

  The change value of White blood cell count between preoperative and postoperative

  Day 2 before surgery、hour 3 after the surgery

• Neutrophils granulocyte change value

  The change value of Neutrophils granulocyte between preoperative and postoperative

  Day 2 before surgery、hour 3 after the surgery

• Hemoglobin change value

  The change value of Hemoglobin between preoperative and postoperative

  Day 2 before surgery、hour 3 after the surgery

• Hematocrit change value

  The change value of Hematocrit between preoperative and postoperative

  Day 2 before surgery、hour 3 after the surgery

• Rate of renal subcapsular hematoma

  The proportion of postoperative renal subcapsular hematoma in all patients

  Day 2 after the surgery

• Serum creatinine change value

  The change value of Serum creatinine between preoperative and postoperative

  Day 2 before surgery、Hour 3 after the surgery

• visual analog scale (VAS)pain score

  0: no pain; Less than 3 points: mild pain, tolerable; 4 points to 6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep.

  Hour 2 after the surgery

• Rate of hydrothorax

  Hydrothorax appeared on the surgical side.

  Day 2 after the surgery

Secondary Outcomes (4)

• Stone free rate

  Day 2 after the surgery

• Operation time

  During the procedure

• length of hospital stay

  2 weeks after surgery

• Medical costs

  2 weeks after surgery

Study Arms (2)

without reverse insertion of a ureteral catheter

EXPERIMENTAL

Percutaneous nephrolithotomy without reverse insertion of a ureteral catheter

Procedure: PCNL without reverse insertion of a ureteral catheter

Conventional

NO INTERVENTION

Percutaneous nephrolithotomy with reverse insertion of a ureteral catheter

Interventions

PCNL without reverse insertion of a ureteral catheter PROCEDURE

The ureteral catheter was not retrograde inserted during PCNL

without reverse insertion of a ureteral catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · Patients with upper urinary tract stones who were 18 years of age or older and eligible for PCNL surgery.

You may not qualify if:

• patients with infectious calculi confirmed by preoperative CT examination and blood biochemical indexes.
• Patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications.
• Patients with previous history of PCNL surgery on the affected side or nephrotomy.
• Patients with indwelling double J tube or nephrostomy tube before operation.
• Patients with renal trauma or congenital anomalies of urinary system.

Sponsors & Collaborators

• The First Affiliated Hospital of University of South China: lead

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingyong Li, MD.

  the First Affiliated Hospital of the University of South China

  STUDY DIRECTOR

Central Study Contacts

Mingyong Li, MD.

CONTACT

137-8648-4606; myli1123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: November 3, 2022
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the study report was published,but the duration is uncertain.
• Access Criteria: When proper editing or review requirements are met, the study data will be available from the study manager after the study is completed.

Locations

CN (1)