A study protocol for a multi-specialty observational cohort comparing robotic stapler and bedside stapler outcomes in robotic-assisted surgeries

Abstract

Introduction Surgical staplers are essential tools in minimally invasive surgery (MIS), enabling tissue division, hemostasis, and secure anastomoses. With the growth of robotic-assisted surgery, robotic staplers such as SureForm have recently become available. These staplers offer precise articulation and real-time tissue compression monitoring. However, the clinical advantages of robotic staplers over bedside staplers remain uncertain. Studies show mixed results across specialties, mainly due to small sample sizes, outdated data, and data heterogeneity. This study protocol proposes a series of future analyses that will evaluate the clinical outcomes and resource utilization of robotic versus bedside staplers in robotic-assisted surgeries across multiple specialties using recent real-world data. Methods and analysis This retrospective cohort study will use data from the Premier Healthcare Database (PHD), a large hospital-based database covering patients with varied payers across the United States. Adult patients (≥18 years) who underwent elective, fully robotic-assisted lung, colorectal, gastric, or bariatric surgeries from 2019 to 2023 will be included. Each surgical specialty will be analyzed in a separate paper. Patients will be categorized into two groups based on the type of surgical stapler used: robotic staplers (SureForm) and bedside staplers (manual or powered). The primary outcome will be postoperative leak (air leak for lung resection; anastomotic leak for colorectal, gastrectomy, and bariatric). Key secondary outcomes are other complications, conversion to open surgery, operative time, transfusion requirements, length of stay (LOS), and cost. Overlap weighting will be applied to minimize bias. Dissemination Results will be disseminated through peer-reviewed surgical journals and presentations at relevant surgical meetings.