Prone Split-Leg vs Galdakao-Modified Supine Valdivia Position During Endoscopic Combined Intrarenal Surgery: A Noninferiority Design Randomized Controlled Trial

Abstract

Endoscopic combined intrarenal surgery (ECIRS) combines percutaneous nephrolithotomy and ureteroscopy. This procedure has become common with the development of the prone split-leg (PRO) and Galdakao-modified supine Valdivia (GMSV) positions. In this study, we evaluated the surgical outcomes of these positions during ECIRS. A noninferior randomized controlled trial was performed in accordance with the Consolidated Standards of Reporting Trials. The eligibility criteria were age 20 to 80 years and presence of > 15-mm renal and/or ureteral stones. They were assigned to the PRO or GMSV groups and underwent ECIRS in the PRO or GMSV position, respectively. The primary outcome was stone-free rate (SFR) 3 months after surgery. The secondary outcomes were surgical outcomes—surgery time, percutaneous access time, and complication rate. A noninferiority margin of 30% was used. Eighty-six patients (46 in the PRO group and 43 in the GMSV group) were analyzed. The SFR was 91.3% and 90.7% in the PRO and GMSV groups, respectively. No between-group differences were observed regarding the overall complication rates. Percutaneous access time was longer in the PRO group than in the GMSV group for upper calyx punctures, whereas surgery and percutaneous access times were shorter in the PRO group for those with a middle calyx puncture. Surgical position did not affect the success rates. There was no difference in complications between the groups, except for perinephric hematoma formation.