Background It is critical to ensure appropriate and consistent sleeve size and orientation during laparoscopic sleeve gastrectomy (LSG). Various devices are used to achieve this, including weighted rubber bougies, esophagogastroduodenoscopy (EGD), and suction calibration systems (SCS). Prior reports suggest that SCSs may decrease operative time and stapler load firings but are limited by single-surgeon experience and retrospective design. We performed the first randomized controlled trial comparing SCS against EGD in patients undergoing LSG to investigate whether the SCS decreases the number of stapler load firings. Methods This was a randomized, non-blinded study from a single MBSAQIP-accredited academic center. Appropriate LSG candidates >= 18 years of age were randomized to EGD or SCS calibration. Exclusion criteria included prior gastric or bariatric surgery, detection of hiatal hernia before surgery, and intraoperative hiatal hernia repair. A randomized block design was employed controlling for body mass index, gender, and race. Seven surgeons employed a standardized LSG operative technique. The primary endpoint was the number of stapler load firings. Secondary endpoints were operative duration, reflux symptoms, and change in total body weight (TBW). Endpoints were analyzed via t-test. Results A total of 125 LSG patients (84% female) underwent study enrollment, with an average age of 44 +/- 12 years and average BMI of 49 +/- 8 kg/m(2). Overall, 117 patients were randomized to receive EGD (n = 59) or SCS (n = 58) calibration. No significant differences in baseline characteristics were identified. The mean number of stapler load firings for EGD and SCS groups were 5.43 +/- 0.89 and 5.31 +/- 0.81, respectively (p = 0.463). The mean operative times for EGD and SCS groups were 94.4 +/- 36.5 and 93.1 +/- 27.9 min, respectively (p = 0.83). There were no significant differences in post-operative reflux, TBW loss, or complications. Conclusion Use of EGD and SCS resulted in a similar number of LSG stapler load firings and operative duration. Additional research is needed to compare LSG calibration devices in different patients and settings to optimize surgical technique.
