Effect of ureteric access sheath on outcomes of retrograde intrarenal surgery for renal stone disease: a randomized controlled trial.

Background: The need of ureteric access sheath (UAS) in retrograde intrarenal surgery (RIRS) has been controversial for gaining high success in terms of stone free rate (SFR), reducing operative times and complications. There has been lack of high level of evidence in the literature on this topic.

Materials And Methods: This prospective randomized controlled trial (RCT) was conducted in the Department of Urology, PGIMER, Chandigarh from July 2019 to Dec 2021. The effect of UAS on the outcome of RIRS (SFR, operative time and complications) for renal stone disease was assessed. Ninety patients were randomized into two groups: 41 patients in Group 1 (RIRS with UAS) and 40 patients in Group 2(RIRS without UAS) were finally analyzed after exclusion. All the patients underwent preoperative double J stent placement at least 10 days prior to the definitive procedure. Operative time was recorded and postoperative pain was assessed by visual analogue scale(VAS) at 6 and 24 h postoperatively. Complications and emergency visits were recorded up to one month post procedure. SFR was assessed at 1 month using noncontrast CT KUB. Success was defined as absence of any residual fragment more than 3 mm in maximum diameter.

Results: Demographic parameters (age, body mass index, and comorbidities) and preoperative parameters (stone burden, proportion of recurrent stone formers and proportion of patients with inferior calyceal stones) were comparable between the two groups. Operative times (45.49 vs 48.38 min; p - 0.484) and VAS scores at 6 and 24 h post-op (p - 0.577) were also comparable between Group 1 and Group 2. SFR was comparable in Group 1 and Group 2 (78.05% vs 80%, p - 0.829). Postoperative complications were higher in the UAS group, but not statistically significant (4.88% vs 0%; p - 0.157).

Conclusion: The use of UAS during RIRS is not associated with improved SFR. RIRS can be performed safely without the use of UAS and without increasing postoperative complications.