Total Tubeless Percutaneous Nephrolithotomy Without a Ureteral Catheter

NCT05578807 | Unknown DMC

• 1 other identifier: 2020SK51801
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Total tubeless Percutaneous nephrolithotomy (PCNL) is a modified surgical method of PCNL surgery, that is, there is no indwelling nephrostomy tube and double-J tube during PCNL surgery. Compared with traditional PCNL surgery, it has the advantages of reducing pain, shortening operation time and reducing operation cost. Since this procedure was first performed in 2004, several randomized clinical studies have verified the safety and efficacy of total tubeless PCNL. Conventional total tubeless 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, a large number of literature reports and the surgical experience of PCNL in the past 20 years tell the investigators that the reverse insertion of ureteral catheter can cause many recent surgical complications.The study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the total tubular 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

  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)

Total tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter

EXPERIMENTAL

In total tubeless percutaneous nephrolithotomy surgery, there is no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no need to change the position, and no need to re-sterilize and lay towels.

Procedure: without reverse ureteral catheter insertion

Conventional total tubeless percutaneous nephrolithotomy

NO INTERVENTION

In total tubeless percutaneous nephrolithotomy surgery, there is reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, need to change the position, and need to re-sterilize and lay towels.

Interventions

without reverse ureteral catheter insertion PROCEDURE

In contrast to conventional total tubeless percutaneous nephrolithotomy, there was no reverse insertion of a ureteral catheter by transurethral ureteroscopy when a patient is placed in lithotomy position, no change in position, and no repeated disinfection.

Total tubeless percutaneous nephrolithotomy 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 kidney stones who met the indications for PCNL surgery.
• the maximum diameter of calculi was less than 35 mm.
• the width of hydronephrosis effusion was less than 25mm.

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 6, 2022
• First Posted: October 13, 2022
• Study Start: September 28, 2022
• Primary Completion: October 10, 2024
• Study Completion: January 10, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

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)