1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drpramod.0702@gmail.com].
   


6. For how long will this data be available start date provided 08-04-2023 and end date provided 08-04-2025?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Introduction: Placement of double J stent (DJ stent) is routine following endourological surgical interventions for urinary tract stone disease. Main complications following these procedures are urinary tract infection (UTI) and stent related symptoms (SRS ), which hamper daily activities. There is lack of literature about appropriate antibiotic strategy following uncomplicated endourological surgery for upper urinary tract stone disease in patients who are on DJ stent. Many clinicians give a continuous low dose antibiotic treatment for entire stent indwelling time to prevent UTI and also possibly reduce SRS. Our study will be conducted to evaluate incidence of UTI and stent related symptoms (SRS) in patients given a peri interventional antibiotic prophylaxis only vs a continuous low dose antibiotic treatment for entire stent indwelling time.

Objectives: To evaluate incidence of UTI and SRS in patients given a peri interventional antibiotic prophylaxis only vs a continuous low dose antibiotic treatment for entire stent indwelling time.Also to note any drug related side effects.

Methods: All patients will be evaluated with thorough medical history, physical examination, blood chemistry test, midstream urine sample analysis and culture. All patients will receive peri interventional antibiotic prophylaxis that is intravenous cefotaxime 1 gm at the time of anaesthesia induction. Patients who had complete stone clearance with DJ stent placed will be selected for the study. Patients will be randomised into 2 groups by lottery method or odd or even number. Group A – No antibiotic treatment from the time of discharge up to removal of the stent (4 weeks). Group B – Low dose continuous antibiotic treatment for entire stent indwelling time, that is nitrofurantoine tablet 100 mg at bedtime from the time of discharge up to removal of stent (4 weeks).

Inclusion criteria - sterile urine culture prior to procedure, complete stone clearance, no fever or antibiotic treatment within past 2 weeks of procedure.

Exclusion criteria – Positive urine culture prior to surgery, incomplete stone clearance, patients who are already on antibiotics.

Total sample of 100 cases will be considered through convenience type of sampling (on an average 8-10 patients are operated for upper urinary tract urolithiasis in an month, overall 120 cases in an year. Considering 10% may not be willing to give consent and10% may not fit into inclusion criteria).

Of these 100 patients, 2 groups will be made with 50 patients in each group.

Follow-up evaluation

   Patients will be evaluated at 1, 2 and 4 weeks for Stent related symptoms and urine culture evaluation. Clinical symptoms of UTI and SRS are very similar, therefore positive urine culture will be used to distinguish UTI from SRS. Clinical symptoms with positive urine culture will be considered as UTI, and clinical symptoms with negative urine culture will be considered symptoms related to stent insitu. Our primary objective will be UTI and secondary objective will be SRS and drug side effects. Any patients with symptomatic UTI will be given full dose antibiotic treatment according to antibiotic resistance pattern. Drug side effects will also be evaluated like gastro intestinal symptoms, cough.

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