Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery

NCT05018546 | Completed DMC

• 1 other identifier: 21/(6-11)/E2/077/078
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Urinary Tract Infections; Ureteric Injury; Sepsis

Outcome Measures

Primary Outcomes (2)

• INFECTION

  urinary tract infection, sepsis, septic shock

  within 30 days

• stone clearance

  stone clearance assessed with x-ray and USG abdomen

  within 30 days

Study Arms (2)

Gravity Irrigation

EXPERIMENTAL

RIRS under Gravity irrigation

Procedure: Irrigation force

Pressure Irrigation

EXPERIMENTAL

RIRS under Pressure irrigation.

Procedure: Irrigation force

Interventions

Irrigation force PROCEDURE

RIRS with different irrigation force

Gravity Irrigation; Pressure Irrigation

Eligibility Criteria

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

You may qualify if:

• Symptomatic renal stone \<2cm in renal pelvis, upper, middle pole calyx or pelviureteric junction
• Lower pole stone \< 1cm
• Lower pole stone 1-2 cm when PCNL is contraindicated or not patient's preference
• Asymptomatic stone of size \>15 mm

You may not qualify if:

• Age below 18 yrs
• Stone \>2 cm
• Ureteric stone

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead
• Nepal Health Research Council: collaborator

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Urinary Tract Infections; Sepsis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Purushottam Parajuli, MBBS,MS

  Tribhuvan University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 24, 2021
• Study Start: September 24, 2020
• Primary Completion: September 24, 2021
• Study Completion: December 24, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 5 years
• Access Criteria: Government research body, Journal editors, authors who request will be provided

Locations

NE (1)