Outpatient surgery with telemonitoring comparable to standard care
Outpatient bariatric surgery supported with telemonitoring is clinically comparable to standard overnight bariatrics in terms of textbook-outcome and offering same-day discharge reduces the total hospitalisation days while maintaining patient satisfaction and safety, according to the outcomes from a randomised clinical trial by researchers from The Netherlands.
The authors designed their patient preference randomised trial to establish and evaluate non-inferiority and feasibility of an outpatient recovery pathway after bariatric surgery, supported by remote monitoring compared to standard care. They note that, thus far, studies on the feasibility and safety of using remote monitoring devices for patients after surgery remain limited.
The non-inferiority study compared the outcomes of two different recovery pathways after bariatric surgery (at the Catharina Hospital, Eindhoven, The Netherlands), namely;
Standard care (SC) - discharge on postoperative day one after one overnight admission.
Intervention group - patients were discharged the same-day which was supported by remote monitoring (RM) using the Healthdot system - a wearable data logger that collects heart rate, respiratory rate, activity and posture continuously by means of accelerometer signals - for seven days after surgery.
From March 2021 to November 2021, a total of 202 patients were analysed (RM n=102, and SC n=100).
The primary outcome was a combined measurement of mortality, mild and severe complications (Clavien-Dindo 2 and higher), hospital readmission or prolonged length of stay (>2 hospitalization days after surgery), within 30 days after surgery (also known as Textbook Outcome)
Textbook Outcome was achieved in 96/102 (94%) in the RM group versus 98/100 (98%) in the SC group. The per protocol result was 62/66 (94%) in the RM group vs. 98/100 in the SC group. According to ITT analysis, the relative risk (RR) comparing Textbook Outcome measures between RM and SC was 2.9 (95% CI, 0.60–14.23, p=0.22) and ARD 3.8% (95% CI, -1.45–9.2). Textbook Outcomes of both groups were above the Dutch average of 88.7% (RM 5.3% and SC 9.3%).
There was zero mortality or adverse events in either group, and the mild complications registered in the RM group were a prescription of oral antibiotics to treat an infected hematoma and a endoscopic clipping on postoperative day one requiring readmission after initial same-day discharge. In the SC group, severe complications included three patients from the RM group who required re-surgery due to postoperative bleeding. In the RM and SC groups each, one patient was readmitted on postoperative day one after teleconsultation and on day four, respectively. Both readmissions were for observation of nausea and vomiting (Clavien-Dindo 1). There was no need to administer intravenous fluids.
Discharge on postoperative day zero was achieved in 66/102 (65%) of RM patients. In 30/102 (29%), the patients went home on postoperative day one. The total number of hospitalsation days was significantly lower in the RM group (61% p<0.001 concerning initial hospital stay and 58% p<0.001 when including readmissions). No differences were found in the total number of hospital days of patients in the RM group who underwent a RYGB or an SG (21 versus 23 days, respectively). Patients who received remote care were equally satisfied vs. patients in the SC group (8.0 ± 1.6 versus 8.0 ± 1.4 respectively p=0.86, 95% CI -0.4–0.5).
“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,” the authors concluded. “Additionally, offering same-day discharge reduces the total hospitalisation days while maintaining patient satisfaction and safety.”
The outcomes were reported in the paper, ‘Telemonitoring for perioperative care of outpatient bariatric surgery: Preference-based randomized clinical trial’, published in PLOSone.
To access this paper, please click here