The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration.

BACKGROUND: Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established. METHODS: To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients. RESULTS: The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care. CONCLUSIONS: Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

Integrated bioabsorbable tissue reinforcement in laparoscopic sleeve gastrectomy.

Division of the stomach in laparoscopic sleeve gastrectomy may be performed using bare stapler cartridges or cartridges fitted with tissue reinforcement strips, with or without oversewing. Many tissue reinforcement strips are after-market add-on products that must be fitted onto a stapler during surgery. A retrospective review was conducted of 85 consecutive patients undergoing laparoscopic sleeve gastrectomy using a novel integrated bioabsorbable polymer buttress pre-mounted on a single-use loading unit stapler. Mean preoperative body mass index (BMI) was 41.7 ± 5.2 kg/m(2). Morbidity and short-term outcomes were documented. Mean follow-up was 8.1 ± 3.6 months (range, 1.0-16.2 months). There were no mortalities or staple line leaks noted in this series with short-term follow up. The major complication rate (grade III and above) was 7.1% and included: reoperation for staple line bleeding (2.4%, n = 2), gastric sleeve stenosis requiring balloon dilation (2.4%, n = 2), choledocholithiasis 2 weeks after surgery (1.2%, n = 1), and reoperation without abnormality for suspected perioperative obstruction (1.2%, n = 1). Mean percent excess BMI loss at 3 (44.6 ± 11.3), 6 (57.9 ± 17.2), and 12 months (72.4 ± 27.5) was comparable to other published series. The use of an integrated absorbable synthetic polymer for stapled tissue reinforcement in laparoscopic sleeve gastrectomy appears to be feasible and safe, and yields results consistent with other published techniques.