We appreciate the comments and observations made by the author regarding our article.[1] Our study was conducted in a prospective manner from May 2020 to May 2021, after approval from the Hospital Ethics Committee (ECRHS/2020/04/01, dated April 15, 2020). The study was not registered with the Clinical Trials Registry of India.
To our knowledge, there was no study published that compared thulium fiber laser (TFL) with holmium (Ho:YAG) laser lithotripsy in the mini-perc procedure for urolithiasis at the time of initiation of our study. The sample size was estimated based on the previously published paper by Enikeev et al.,[2] on the use of TFL in percutaneous nephrolithotomy in which 120 patients were included in a proof-of-concept study with no comparison group. We could enroll 66 and 59 patients in Ho:YAG and TFL groups, respectively, due to COVID-19 situation, and based on the recommendation from the statistician, we decided to discontinue the patient enrolment and presented the interim analysis.
The randomization numbers were generated by someone who was not part of the study and secured them in sequentially numbered, opaque, and sealed envelopes. These envelopes were opened after patients' eligibility was confirmed and the consent was secured. Blinding was not performed in the study, which may have its inherent limitations. There were no exclusions due to nonavailability of consent, lost to follow-up or conversion to standard Percutaneous Nephrolithotomy (PCNL) during the surgery.
Stones in anomalous kidney like horseshoe and malrotated kidney were included in the study.
The primary outcome was the stone disintegration time for TFL and Ho:YAG laser in mini-percutaneous nephrolithotomy procedure. The difference in the stone-free rates between TFL (94.2%) and Ho:YAG laser (90.9) was not statistically significant (P = 0.498). The mean drop in hemoglobin after surgery was comparable between the two groups, 1.3 g/dl (TFL) and 1.1 g/dl (Ho:YAG). We apologize for the error in the article.
Footnotes
Financial support and sponsorship: Nil.
Conflicts of Interest: There are no conflicts of interest.
REFERENCES
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