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Treatment of Calculous Pyonephrosis With 0.5% Iodophors for I-stage PCNL

NCT03805542 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2019-08-07

No results posted yet for this study

Summary

Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on the kidney function. Most stone operations can be performed in one stage, but there is still some controversy about whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce pyuria caused by influenza, and then stone removal should be done in the second stage. However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs and increased family burden. Based on the current treatment status of pyonephrosis patients, previous animal experimental results and volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I percutaneous nephrolithotomy(PCNL) after iodophor disinfection of renal collecting system.

Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants. Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine 5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly and persistently.

At present, clinical studies on calculous pyonephrosis at home and abroad are mostly single-center, small sample studies, and lack of randomized controlled clinical trials. In view of the current situation and animal experimental results, we intend to carry out a clinical trial of "iodophor treatment of pyonephrosis and one-stage operation" in order to benefit patients with calculous pyonephrosis.

Conditions

  • Urolithiasis

Interventions

COMBINATION_PRODUCT

0.5% Iodophors

Before lithotripsy, 0.5% iodophor 40 ml(depending on the degree of hydronephrosis) was used to perfuse the calculous side pelvis under low pressure for 5 minutes.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Xinguang Wang, M.A. · Ph.D. Postgraduates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03805542 on ClinicalTrials.gov