Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial

Abstract Background: Vision is an important and defining element of laparoscopy and significantly affects the outcome of an operation regarding time, mistakes, and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD), and two-dimensional (2D) ultra-high-resolution (4K) monitors. 3D HD systems present a number of potential benefits for surgeons and patients compared to the conventional 2D systems with reduced operating time, blood loss, and shortened hospital stay. However, the performance of 3D systems against the new, ultra-high definition 4K systems is barely known and highly controversial. There is a paucity of studies comparing them in clinical settings. The purpose of this study is to compare 2D 4K versus 3D HD perspective in a gastric bypass operation. Methods: Forty-eight patients with indication for gastric bypass will be randomized to receive laparoscopic gastric bypass surgery using either 2D 4K or 3D HD systems. Operations are performed by a well-coordinated team consisting of three senior surgeons. Primary outcome is the operating time. Secondary outcomes include intraoperative complications, blood loss, the workload of the operator evaluated through the validated Surg-TLX questionnaire and postoperative complications according to the Clavien-Dindo classification. One interim analysis is planned after the enrolment of twelve participants for each group. Discussion: This prospective randomized trial aims to investigate the hypothesis stating that the use of the 3D HD system yields a significant improvement in operating time compared to a 2D 4K system in bariatric surgery. The purpose is to provide clinical evidence on new laparoscopic imaging systems and assess potential advantages. Trial registration: This trial is registered at clinicaltrials.gov under the identifier NCT05895058. Registered 30 May 2023. BASEC2023-D0014 [Registry ID Swissethics, approved 3 May 2023]. SNCTP000005489 [SNCTP study register, last updated 13 July 2023].