Peri-operative (Continuous) Remote Patient Monitoring of Patients Undergoing Major Gastrointestinal Surgery: a Feasibility Study

Complex gastrointestinal surgery is associated with high incidence of
complications, up to 60% depending on the type of surgery. With the increasing
age these types of surgery (e.g., colectomy, esophagectomy) are performed more
frequently. Early detection of deterioration of patients after surgery and
subsequent early intervention could lead to less morbidity on short- and long
term. For early detection, (continuous) remote patient monitoring using Ehealth
devices has shown potential. However, the use of (continuous) monitoring of
vital parameters in clinical practice is still in its infancy. Therefore, this
study focuses is a feasibility study to the use of perioperative remote patient
monitoring using a wearable device for continuous monitoring together with
other Ehealth devices and questionnaires for early detection of abnormal
postoperative recovery, implying possible adverse events.

The aim of this study is to determine the feasibility of perioperative
(continuous) remote patient monitoring using Ehealth devices and a daily
questionnaire in patients undergoing major gastrointestinal surgery.
Additionally, to determine (early) signs (e.g., vital signs, questionnaire
answers) of postoperative complications. Ultimately, this should lead to
alterations in perioperative care to improve patients care and surgical
outcomes.

This is a monocenter feasibility study, during this study patients undergoing
major gastrointestinal surgery are using CE-marked Ehealth devices for
(continuous) remote patient monitoring. Alongside these devices patients will
be asked to fill-out a the MD Anderson Symptom Index (MDASI) questionnaire
supplemented with the Dutch Postoperative Gastrointestinal Status Scale
(DPGSS), concerning their health-status and recovery every day. The study
consists of an observational study design, therefore all measurements and
questionnaires will be blinded until the end of a patients study period, thus
no clinical decisions are taken based on the measurements or questionnaire
answers. The study period will be starting 4 days before admission until 7 days
after discharge.

Patients who consent to take part in the study will receive a Healthdot device:
a thorax-located patch which continuously monitors heart rate, respiratory
rate, activity, and posture. The monitoring starts up to 4 days before surgery
and takes until the 14th day after discharge. Additionally, in the
out-of-hospital setting before and after admission, patients receive a *Box*
with eHealth devices to monitor all vital signs twice a day. During phase I of
the study the measurements are blinded, thus no clinical decisions are taken
based on the measurements. In phase IIa, an algorithm based on the modified
early warning score (MEWS) is used, during phase IIb an AI algorithm based on
the data obtained during phase I, is used to alarm nurses of abnormal vital
signs.

This study aims to pave the way for future studies and ultimately
implementation of Ehealth in perioperative care leading to improved surgical
outcomes, reduced workload on the surgical ward and enchanced patient
satisfaction. The Box consists of CE-marked devices used in this study are
non-invasive, easy-to-use and electrically safe, therefore the risk of using
the devices is very limited. The study has no benefits for participants, since
measurements and questionnaire answers are blinded for healthcare
professionals, and therefore no medical decisions are made based on the
measurements or daily questionnaire answers. Participation requires commitment,
since participants need to wear a Healthdot, perform vital sign measurements
twice a day and answer a questionnaire every day for the study period.
Furthermore, participants have to fill out a questionnaire at the end of the
study. This study does not present potential benefits for participating
patients, however this study is an important first step for future studies and
ultimately implementation of remote patient monitoring to enhance perioperative
care and oucomes. We therefore believe this study is ethically justified.