Randomized controlled trial of traxi panniculus retractor use during non-emergent cesarean delivery.

Objective: The objective of our study is to determine whether the use of a self-retaining panniculus retraction device (traxi) in patients with obesity will improve operative time, pulmonary function, or patient and provider experience for non-emergent cesarean delivery. Methods: Pregnant patients with body mass index (BMI) ≥40 kg/m Results: We enrolled 135 participants from 2018 to 2024 at two academic hospitals; 67 were randomized to traxi and 68 were randomized to no traxi. Of these, 43 (31.9%) reported no prior abdominal surgery (including prior cesarean or other laparotomy) and the median BMI was 48.9 (interquartile range [IQR] 45.0, 52.5). The trial was terminated before the target sample size of 220 participants was achieved due to slow accrual and waning clinical equipoise. Baseline characteristics of each group were similar. Median surgical time was 65.0 min (IQR 55.0, 81.0) in the traxi group and 70.0 min (IQR 57.0, 86.0) in the no traxi group, but this difference was not statistically significant ( Conclusions: Traxi panniculus retraction did not significantly improve surgical time but was associated with less restrictive pulmonary function testing compared with the control arm; these findings should be interpreted in the context of the study's limited sample size. There were higher reports of provider satisfaction with use of traxi compared to the control arm. Patient-reported satisfaction with use of traxi was high but not statistically different when compared to the control arm with the exception of patient-reported rash (less in traxi arm).