ABSTRACT
A hybrid technique of robot-assisted, laparoscopic hysterectomy using the ENSEAL(®) Tissue Sealing Device is described in a retrospective, consecutive, observational case series. Over a 45 month period, 590 robot-assisted total laparoscopic hysterectomies +/- oophorectomy for benign and malignant indications were performed by a single surgeon with a bedside assistant at a tertiary healthcare center. Patient demographics, indications for surgery, comorbidities, primary and secondary surgical procedures, total operative and surgical time, estimated blood loss (EBL), length of stay (LOS), complications, transfusions and subsequent readmissions were analyzed. The overall complication rate was 5.9% with 35 patients experiencing 69 complications. Mean (SD) surgery time, operating room (OR) time, EBL, and LOS for the entire cohort were 75.5 (39.42) minutes, 123.8 (41.15) minutes, 83.1 (71.29) millilitres, and 1.2 (0.93) days, respectively. Mean surgery time in the first year (2009) was 91.6 minutes, which declined significantly each year by 18.0, 19.0, and 24.3 minutes, respectively. EBL and LOS did not vary -significantly across the entire series. Using the cumulative sum method, an optimization curve for surgery time was evaluated, with three distinct optimization phases observed. In summary, the use of an advanced laparoscopic tissue-sealing device by a bedside surgical assistant provided an improved operative efficiency and reliable vessel sealing during robotic hysterectomy.
ABSTRACT
Study-level design characteristics that inform the optimal design of obesity randomized controlled trials (RCTs) have been examined in few studies. A pre-randomization run-in period is one such design element that may influence weight loss. We examined 311 obesity RCTs published between 1 January 2007 and 1 July 2009 that examine d weight loss or weight gain prevention as a primary or secondary end-point. Variables included run-in period, pre-post intervention weight loss, study duration (time), intervention type, percent female and degree of obesity. Linear regression was used to estimate weight loss as a function of (i) run-in (yes/no) and (ii) run-in, time, percent female, body mass index and intervention type. Interaction terms were also examined. Approximately 19% (18.6%) of the studies included a run-in period, with pharmaceutical studies having the highest frequency. Although all intervention types were associated with weight loss (Mean = 2.80 kg, SD = 3.52), the inclusion of a pre-randomization run-in was associated with less weight loss (P = 0.0017) compared with studies that did not include a run-in period. However, this association was not consistent across intervention types. Our results imply that in trials primarily targeting weight loss in adults, run-in periods may not be beneficial for improving weight loss outcomes in interventions.
