Efficacy and Safety of a Novel Handheld Robotic Needle Holder Versus Conventional Instrument in Laparoscopic Ureterolithotomy: A Multicenter, Randomized, Single-Blind, Positive Parallel Controlled, and Noninferiority Clinical Trial.

Abstract

Purpose: This study aimed to validate the efficacy and safety of the HTH-1 handheld robotic needle holder versus conventional instrument in laparoscopic ureterolithotomy. Methods: This is a noninferiority clinical trial conducted in three hospitals. Patients were enrolled and randomly allocated into the experimental or control group on whom laparoscopic ureterolithotomy was performed with the ureteral incision sutured using the HTH-1 and conventional needle holder, respectively. The average suture time per stitch (STPS) of ureter was calculated as the primary efficacy indicator. Postoperative drainage volumes were recorded, and the instruments' operating performance was subjectively evaluated and compared between groups. Adverse events occurred during the trial and interference of the instruments to the monitor were assessed as the safety indicators. Results: From April to September 2018, 50 patients were enrolled with 25 ones in each group. For the efficacy indicators, the noninferiority of the STPS was determined when the noninferiority margin was 40 seconds. The postoperative drainage volumes were not significantly different between groups. The instruments' operating performance was rated as smooth in all cases of both groups. For the safety indicators, no adverse events or interference of the instruments to the monitor occurred during surgery in any case. Clavien 1 complications occurred in 7 (4 in the experimental group versus 3 in the control group, P = 1.000) patients after surgery. Conclusions: The HTH-1 is effective and safe and noninferior to conventional needle holder in laparoscopic ureterolithotomy. Adequate training and skills assessment are needed before application on patients. Clinical trial registration: The clinical trial registration was completed in Jiangsu Provincial Drug Administration (record number: Suxielinbei 20180018).