Patients were assessed by a multidisciplinary surgical team involving surgeons, anesthesiologists, and nurses. The ERAS process was carefully explained to each patient. Our center’s detailed ERAS protocol has been previously described [
]. During preoperative consultation, patients were informed about the specific management strategy for follow-up, including early discharge at postoperative day one (with satisfactory postoperative progress) using Internet-connected at-home monitoring.
The day before surgery, patients were called by a medical secretary to confirm the hour of surgery. Patients were asked to perform “modern fasting,” which stipulates a light meal the night before surgery, and oral intake of a 400-mL carbohydrate-loaded drink 2 h before surgery.
No preoperative sedative was used, and anesthetic agents with a short duration of action were employed. Systemic intraoperative and postoperative analgesia was utilized to prevent postoperative pain, nausea, and vomiting, and to minimize narcotic use. Local anesthetics (e.g., ropivacaine 7.5 mg) were administered, and at port sites, intraperitoneal local anesthetic (IPLA) [
Compression socks were used intraoperatively rather than pneumatic stockings. Procedures were performed under laparoscopy by 2 experienced surgeons. Neither drains nor nasogastric tubes were used. Skin closure was performed with absorbable sutures and strips.
After surgery, patients were supervised in the recovery room for about 1 h. Upon departure from the recovery room, the peripheral intravenous line was closed to facilitate patient movement. On return to the surgical unit, patients received no intravenous perfusion; only oral analgesia was administered. Patients were allowed to drink 4 h after surgery and were mobilized by the physiotherapist to walk.
On the first postoperative day, a blood test was performed to evaluate hemoglobin and C-reactive protein (CRP) levels. Prior to leaving the clinic, patients attended a nutritionist discharge meeting. Thrombophylaxis agents were selectively prescribed to high-risk morbidly obese patients (assessed postoperatively by Caprini score strictly > 3) [
]. Our postoperative thrombophylaxis protocol is reported in a previous study [
]. All patients were invited to a 1-month postoperative consultation where they were asked to complete a paper satisfaction survey.
The connected surveillance is a “cloud-based” software as a service (SaaS) solution. It operates fully independently from any other information technology system. The hosting partner, certified by the French Ministry of Heath, has implemented an Information Security Management System (ISMS) for cloud operations, and follows the ISO27001:2013 standard. The platform comprises 2 modules as follows: a patient engagement module accessible to the patient as a native mobile application and a web application for all desktop and laptop computers and browsers. In addition, the patient’s care team also has access to a management application module to review the patient’s data and track his/her progress and health status.
The protection of personal data is ensured using multiple mechanisms. Access is restricted and protected with strong authentication. The platform uses role-based access control mechanisms to ensure staff access to personal data is only on a “need-to-know basis.” Data and communication are encrypted end to end, both in transit and at rest using advanced encryption algorithms (AES 256). Automatic monitoring systems are in place to identify external attempts to penetrate the security of the system. Electronic traffic check is permanently engaged. Data centers used are certified. Data are backed up in a separate geographical location to ensure that in the event of a significant problem in the main data center, service can be restarted from a secondary data center without significant loss of data.
Study Period—At-Home Follow-Up
If patients met the discharge criteria, they were discharged from hospital the day after surgery. After discharge, patients participated in the 10-day follow-up study period (after which, they were given a classic bariatric surgical follow-up plan, including surgical consultations at 1, 3, and 6 months, and as needed). The 10-day study period was regulated by the Internet-connected surveillance protocol which was monitored 24 h per day by specially trained nurses. A total of 25 trained nurses were involved in the connected follow-up. The shift pattern used 2 teams and 2 12-h shifts to provide 24/7 coverage. The surveillance included data collection (patient-reported outcomes) and an automatic alert system to highlight abnormal events.
Patients were invited to choose a surveillance method to connect electronically to either the program website or mobile application. They were instructed to connect at least once a day to complete an online patient-oriented questionnaire (Table
) reporting their current health status and likelihood of emerging complications. The solution promotes and tracks the patient’s ongoing adherence to follow-up. Patients received an alert at 9:00 am. They were required to complete the questionnaire before 1:00 pm. If a patient did not connect online, the application provided a reminder to the patient. If the patient did not complete the questionnaire at all, nurses received an alert as well and directly called the patient. The daily questionnaire aimed to capture any clinical side effects of surgery (e.g., fever, nausea, pain). The clinical results were sent to the surgeon daily by email; at any time, the surgeon could connect him/herself to the platform and review the details pertaining to any patient. Patients were also allowed to ask specific questions on the web chat or by telephone helpline. At all times, the patient was able to request a callback from nurses.
In order to assist the medical team in diagnosing patients based on their self-reported measures, objective values, such as serum level of CRP, were also systematically evaluated on day 1, 3, 5, and 7. In practice, patients left the hospital with blood test orders. The first blood test on postoperative day one was performed in the hospital. Subsequently, patients were asked to attend an ambulatory laboratory for blood work, and the patient reported the laboratory outcomes in the online platform. The surgeon defined the CRP cut-off level that designated an alert.
Any patient’s self-report or blood analysis that was out of the reference range for postoperative well-being was reported as an alert that the nurse and the surgeon received on their mobile phone through the connected surveillance system. They could elect to contact a patient for additional evaluation, as necessary. To avoid the system triggering a false positive alert, each participating surgeon configured his/her own protocol and adapted them in real time. Nonetheless, to limit costs due to unjustified alerts, each alert was first analyzed by the follow-up nurses who called the patient to clarify the alert.
Analyses were performed using the SPSS statistical package (version 20; IBM, Chicago, IL). Study analysis consisted of calculating simple counts and percentages for categorical data.