Randomized controlled trial evaluating the effect of the use of a laparoscopic lens-cleaning device during laparoscopic colorectal surgery on the multidimensional workload (YCOG1903).

ABSTRACT

BACKGROUND: OpClear® is a newly developed laparoscopic lens-cleaning device that can be attached to a laparoscope. The present study determined whether or not the use of a OpClear® reduces the multidimensional surgery-specific workload of the operator during laparoscopic colorectal surgery for colorectal cancer compared with the reference technique (warm saline) by a randomized controlled trial. METHODS: Patients diagnosed with colorectal cancer and scheduled for laparoscopic colorectal surgery were randomly allocated to the warm saline arm or Opclear® arm. The primary endpoint was the multidimensional workload of the first operator (value of SURG-TLX). The secondary endpoints were the operative time and total number of lens washes outside the abdominal cavity. RESULTS: Between March 2020 and January 2021, a total of 120 patients were enrolled in this study. A total of 4 patients were excluded from the full analysis set. A total of 116 patients (warm saline arm 59 patients, Opclear® arm 57 patients) were therefore analyzed. The baseline factors were well-balanced between the two arms. Regarding SURG-TLX, there was no significant difference in the overall workload between the two arms. Operators in the Opclear® arm required significantly less physical demand than in the warm saline arm (Opclear® arm 6, warm saline arm 7; p = 0.046). The operative time was similar between the two arms. The total number of lens washes outside the abdominal cavity in the Opclear® arm was significantly lower than that in the warm saline arm (Opclear® arm 2, warm saline arm 10; p < 0.001). CONCLUSIONS: There was no significant difference in the overall workload, but the physical demand and total number of lens washes outside the abdominal cavity were significantly lower in the Opclear® arm than in the warm saline arm. The use of this device may thus help reduce operator stress in terms of physical demand. The study was registered with the Japanese Clinical Trials Registry as UMIN0000038677.