Conventional stent placement versus no stent placement after Ureterorenoscopic Lithotripsy for ureteric calculi –A randomized controlled study

Title Conventional Stent Placement Versus No Stent Placement After Ureteroscopic Lithotripsy for Ureteric Calculi A Randomized Controlled Study

Introduction Urolithiasis affects nearly 8 percent of Indians, with some regions reporting prevalence as high as 22.4 percent. Ureteroscopic lithotripsy URSL is a common treatment, often followed by ureteral stenting to ensure postoperative ureteral patency. However, stents can cause significant discomfort and lower quality of life referred to as stent syndrome. Although professional guidelines suggest stent omission after uncomplicated URSL, over 80 percent of cases still receive stents, largely due to a lack of high quality evidence.

Aims and Objectives The primary aim is to compare outcomes and complications of conventional stent placement versus no stent placement following uncomplicated URSL. Objectives include:

1. Comparing emergency department visits within 30 days post procedure.
2. Assessing quality of life using the Ureteral Stent Symptom Questionnaire USSQ.
3. Documenting and comparing postoperative complications in both groups.

Justification of Study There is no prior study in India that uses the USSQ tool to guide clinical decisions on stent placement. This study aims to provide robust evidence through a randomized controlled design to optimize postoperative protocols and reduce patient morbidity.

Review of Literature Multiple RCTs and meta analyses demonstrate that stented patients experience more pain, lower urinary tract symptoms, and longer hospital stays, without significant improvement in stone free rates or complication prevention. Studies by Reddy et al, Savic et al, Al Demour et al, and Denstedt et al consistently report improved quality of life and fewer symptoms in stentless groups.

Methodology Design Open label, single centre RCT Setting Nazareth Hospital, Shillong Duration 12 months Participants 60 adult patients 18 to 65 years undergoing unilateral URSL for stones up to 15 mm Randomization 1 to 1 to stent Group A or no stent Group B Inclusion Criteria Informed consent, uncomplicated URSL Exclusion Criteria Bilateral URSL, preexisting stent, anatomical anomalies, pregnancy, staged URSL

Risks No additional risks beyond those of standard URSL. Any intraoperative complications requiring stent placement will lead to exclusion from the study.

Outcome Measures Primary Emergency department visits within 30 days Secondary USSQ scores at Day 30 and postoperative complications

Statistical Analysis Sample size 30 per group power 80 percent, alpha 0.05 Tests Chi square or Fishers exact for categorical data; t test or Mann Whitney U for continuous data Software Stata 17 Significance p less than 0.05

National Significance This is one of the first RCTs in India using USSQ to assess post URS outcomes. Findings could influence national surgical protocols and reduce unnecessary stent related morbidity, improving patient quality of care and resource use in urological surgery.