COMPARING THE VISUAL CLARITY OF WATER VERSUS SALINE WHEN USED AS IRRIGANT FLUID IN ENDOSCOPIC URETERIC STONE SURGERY

COMPARING THE VISUAL CLARITY OF STERILE WATER VERSUS NORMAL SALINE AS IRRIGANT IN SEMI-RIGID URETEROSCOPIC LITHOTRIPSY IN ADULT PATIENTS BETWEEN 18 AND 70 YEARS WITH URETERIC STONE DISEASE: AN ADAPTIVE DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL - CLAWS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/023668

Enrollment

150

Registered

2020-03-02

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: Sterile water: Sterile water as irrigant fluid during ureteroscopic lithotripsy Control Intervention1: Normal saline: Normal saline as irrigant fluid during ureteroscopic lithotripsy

Eligibility

Inclusion criteria

Inclusion criteria: a. Adults between 18-70yr with ureteric stone(s), unilateral/bilateral planned for ureteroscopic lithotripsy b. ASA(American Society of Anesthesiologists) physical status less than or equal to 3

Exclusion criteria

Exclusion criteria: a. Age less than 18 yr or more than 70 yr. b. Pregnant women with ureteric stone(s) c. CKD stage 3 and above. d. Pre op Sodium less than 130 meq/l e. Pre op potassium more than 5 meq/l f. ASA(American Society of Anaesthesiologists) physical status more than 3 g. Ureteric stone size more than 2 cm h. Stone at vesico ureteric junction(VUJ) or distal ureteric stone within 1 cm of VUJ

Design outcomes

Primary

Measure	Time frame
Turbidity of fluid, Subjective visual rating by surgeon, Ureteric injury grading post surgery.Timepoint: Turbidity of fluid and Subjective visual rating by surgeon will be measured at specific time points during surgery- just before fragmentation of stone, at 1 minute, at 10 minutes, at 20 minutes and at the end of fragmentation, Ureteric injury grading post surgery will be measured soon after surgery before removing ureteroscope from the body.	—

Measure

Time frame

Turbidity of fluid, Subjective visual rating by surgeon, Ureteric injury grading post surgery.Timepoint: Turbidity of fluid and Subjective visual rating by surgeon will be measured at specific time points during surgery- just before fragmentation of stone, at 1 minute, at 10 minutes, at 20 minutes and at the end of fragmentation, Ureteric injury grading post surgery will be measured soon after surgery before removing ureteroscope from the body.

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Secondary

Measure	Time frame
Stone free rates, Rate of additional treatments at follow up visit (for residual stone fragment in the form of extracorporeal shock wave lithotripsy, stenting or redo ureteroscopic lithotripsy), Duration of stone fragmentation (in minutes), Duration of laser usage (in minutes), Amount of laser energy used (in Joules) Timepoint: Stone free rates, Rate of additional treatments at follow up visit: post operatively at 1 week, Duration of stone fragmentation: from beginning of stone fragmentation to final removal of ureteroscope from body. Duration of laser usage (in minutes), Amount of laser energy used (in Joules)	—

Measure

Time frame

Stone free rates, Rate of additional treatments at follow up visit (for residual stone fragment in the form of extracorporeal shock wave lithotripsy, stenting or redo ureteroscopic lithotripsy), Duration of stone fragmentation (in minutes), Duration of laser usage (in minutes), Amount of laser energy used (in Joules) Timepoint: Stone free rates, Rate of additional treatments at follow up visit: post operatively at 1 week, Duration of stone fragmentation: from beginning of stone fragmentation to final removal of ureteroscope from body. Duration of laser usage (in minutes), Amount of laser energy used (in Joules)

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Countries

India

Contacts

Public ContactAbhik Debnath

CMC Vellore

antonydevasia@cmcvellore.ac.in04162282055

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026