Telemonitoring for perioperative care of outpatient bariatric surgery: Preference-based randomized clinical trial

Abstract

Importance Implementation of bariatric surgery on an outpatient basis is hampered by concerns about timely detection of postoperative complications. Telemonitoring could enhance detection and support transition to an outpatient recovery pathway. Objective This study aimed to evaluate non-inferiority and feasibility of an outpatient recovery pathway after bariatric surgery, supported by remote monitoring compared to standard care. Design Preference-based non-inferiority randomized trial. Setting Center for obesity and metabolic surgery, Catharina hospital Eindhoven, the Netherlands. Participants Adult patients scheduled for primary gastric bypass or sleeve gastrectomy. Interventions Same-day discharge with one week ongoing Remote Monitoring (RM) of vital parameters or Standard Care (SC) with discharge on postoperative day one. Main outcomes Primary outcome was a thirty-day composite Textbook Outcome score encompassing mortality, mild and severe complications, readmission and prolonged length-of-stay. Non-inferiority of same-day discharge and remote monitoring was accepted below the selected margin of 7% upper limit of confidence interval. Secondary outcomes included admission duration, post-discharge opioid use and patients’ satisfaction. Results Textbook Outcome was achieved in 94% (n = 102) in RM versus 98% (n = 100) in SC (RR 2.9; 95% CI, 0.60–14.23, p = 0.22). The non-inferiority margin was exceeded which is a statistically inconclusive result. Both Textbook Outcome measures were above Dutch average (5% RM and 9% SC). Same-day discharge reduced hospitalization days by 61% (p<0.001) and by 58% with re-admission days included (p<0.001). Post-discharge opioid use and satisfaction scores were equal (p = 0.82 and p = 0.86). Conclusion In conclusion, outpatient bariatric surgery supported with telemonitoring is clinically comparable to standard overnight bariatrics in terms of textbook-outcome. Both approaches reached primary endpoint results above Dutch average. However, statistically the outpatient surgery protocol was neither inferior, nor non-inferior to the standard pathway. Additionally, offering same-day discharge reduces the total hospitalization days while maintaining patient satisfaction and safety.

Cirugía Bariátrica en Régimen Ambulatorio: Evidencias de viabilidad y propuestas de implementación

“…El ensayo DAYSLEEVE aleatorizó 1.544 pacientes (777 casos de GV ambulatoria y 777 con ingreso); no hubo ningún caso de reintervención quirúrgica ni mortalidad en ninguno de los dos grupos y solo 18 pacientes (2.3%) del grupo ambulatorio precisaron ingreso para control de dolor o náuseas [27] . El estudio holandés PEACH, cuyo resultado principal era una variable compuesta de morbimortalidad, tampoco encontró diferencias entre grupos [28] .…”