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Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery

NCT05018546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-06-02

No results posted yet for this study

Summary

Urolithiasis is one of the most prevalent urological diseases affecting general population across the world. The available treatment modalities for renal stones are Shock wave lithotripsy (SWL), Percutaneous Nephrolithotomy (PNL), and Retrograde Intrarenal Surgery (RIRS). Irrigation for RIRS is the critical component for the success of procedure. To avoid detrimental effects of high pressure, intra-renal pressure (IRP) has to be lower. Different studies have shown that high irrigation pressure raises intra-renal pressure leading to pyelo-venous and pyelo-lymphatic reflux which can lead to sepsis and septic shock. Comparative study of different irrigation pressure during RIRS is lacking.

This is randomized controlled trial conducted in Department of Urology and Renal Transplant Surgery for duration of one year. Objective of the study is to compare safety and efficacy of gravity irrigation versus pressure irrigation. Patients with symptomatic kidney stones: non lower pole stones \<2cm, lower pole stones \<1cm and lower pole stones 1-2 cm in whom PCNL is contraindicated will be enrolled in study with informed consent. Retrograde intrarenal surgery will be performed as standard procedure and Ho:YAG laser will be used to fragment stones.

Stone free rate at postoperative day 1 and after 1 month will be monitored through X-ray KUB. Maximum irrigation pressure, duration of surgery, stone size, density, location, intraoperative and postoperative complications as classified by Clavien-Dindo will be noted for all patients. Data will be appropriately analyzed and statistical tests applied as necessary.

Conditions

Interventions

PROCEDURE

Irrigation force

RIRS with different irrigation force

Sponsors & Collaborators

  • Nepal Health Research Council

    collaborator OTHER_GOV

  • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    lead OTHER

Principal Investigators

  • Purushottam Parajuli, MBBS,MS · Tribhuvan University Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2021-09-24
Completion
2021-12-24

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Diseases

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 NCT05018546 on ClinicalTrials.gov