Less Morbidity with Robot-Assisted Gastric Bypass Surgery than with Laparoscopic Surgery?

INTRODUCTION: Although several studies have compared totally robot-assisted gastric bypass (RA-GB) to laparoscopic gastric bypass (L-GB), the clinical benefit of the robotic approach remains unclear. MATERIALS AND METHODS: We compared perioperative outcomes of 82 consecutive patients undergoing RA-GB between 2013 and 2016 to 169 consecutive patients having undergone L-GB between 2009 and 2016. Secondary endpoints included duration of hospitalization, readmission rate, weight loss at 1 year, and the learning curve of RA-GB, assessed by operation times and complication rates. RESULTS: There were no statistically significant differences between groups concerning age (43.5 ± 11.2 vs. 42.2 ± 12.4 years), body mass index (42.4 ± 5.0 vs. 43.6 ± 7.2 kg/m2), or comorbidities. The rate of revision surgery was higher in L-GB group without reaching statistical significance. No statistically significant difference was observed for duration of operation (134 ± 35 vs. 135 ± 37 min), readmission rate at 90 days (4.9% vs. 8.9%), or percentage of excess weight loss at 1 year (RA-GB vs. L-GB) (76.8% ± 20.5 vs. 73.1% ± 23.5). There were fewer statistically significant complications overall in RA-GB (9.8% vs. 21.9%, p = 0.019). Median duration of hospital stay was shorter for RA-GB (3 vs. 4 days, p < 0.0001). The mean duration of operation for RA-GB decreased from 153 min in 2014 to 122 min in 2016; p = 0.004. CONCLUSION: In our experience, the robotic approach for gastric bypass was associated with fewer postoperative complications compared to traditional laparoscopic gastric bypass. Cost increment associated with RA-GB remains an important drawback that hampers its widespread.

Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

BACKGROUND: The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). METHODS: We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. RESULTS: Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. CONCLUSION: Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities.