An interventional study of Remote clinical monitoring in Digital Health, sponsored by Jessa Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Jessa Hospital · Not applicable, Interventional, and Supportive care
This feasibility trial has three main objectives:
Due to fast progress and improvements in robotic surgery, minimally invasive procedures for complex surgery have become increasingly feasible for the vast majority of patients. Over recent years, minimally distal pancreatectomy (MDP) has become the preferred approach for distal pancreatectomy. This minimally invasive alternative offers less postoperative pain, better cosmetic outcomes, a quicker recovery, a shorter hospital stay, decreased morbidity, reduced intraoperative blood loss, and reduced health care costs. This shift in care models has enabled patients to return home more quickly after surgery, while their recovery continues to be closely monitored.
Hospitals are increasingly confronted with high bed occupancy rates and the need to use staff more efficiently. This has emphasized the importance of optimizing the length of stay for patients undergoing pancreatectomy, ensuring they can be discharged sooner without compromising their recovery. Early discharge from the hospital, combined with remote monitoring, offers a promising solution to these challenges. Thanks to advances in technology, patients can be monitored remotely after discharge by healthcare professionals allowing for early detection of potential complications and timely intervention, all while the patient recovers in the comfort of their own home. This approach also facilitates the effective implementation of transmurally coordinated care pathways (care delivered across different levels of the healthcare system), ensuring seamless communication and care transitions between hospital and home.
The TOTeM (Transmurale Opvolging met TeleMonitoring na chirurgie) project, supported by the Federale Overheidsdienst Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu, focuses on remote monitoring of patients with the help of wearable monitoring devices and a telemonitoring hub. Unlike the current approach where the patient is admitted to the intensive care unit (ICU) after surgery, patients will be immediately transferred to the ward. The patient is sent home after surgery as early as medically possible (as defined by reaching all of the time to be fit criteria), with qualitative and specialized follow-up in the home setting. The time to be fit criteria include: oral pain medication only, independent walking, oral intake, hemodynamically (90% of baseline blood pressure, heart rate in 90% of normal range) and respiratory (no need for extra oxygen) stable, and no drains or urinary catheters. After discharge, the patient is contacted by the telemonitoring hub through a daily videocall. Parameters are assessed up to three times a day. Follow-up via the mobile application and videocall is foreseen up to ten days postoperatively. The telemonitoring hub screens all input from the questionnaires completed by the patient as well as the parameters that are obtained via wearable monitoring devices. If necessary, the patient is contacted or an escalation protocol is triggered. The project aims to enable a faster recovery of patients in a familiar home environment and a more active role of the patient in their recovery process. For the hospital, the faster discharge offers the opportunity to optimize bed occupancy. On a societal level, the social cost of care may decrease.
This pilot and feasibility study focuses on the application of remote clinical monitoring following robotic distal pancreatectomy. By evaluating the feasibility and effect of the implementation of such a care model, this research aims to contribute to optimizing care for patients undergoing these complex procedures, while also alleviating pressure on hospital resources and staff.
Jessa Hospital is the lead sponsor of 85 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The application of remote clinical monitoring after a distal robotic pancreatectomy
Procedure: Remote clinical monitoring
Patients after a distal pancreatectomy will be discharged faster from the hospital and will be remote monitored
Length of stay in hospital
The primary outcome measurement for the TOTeM care pathway in patients undergoing robotic distal pancreatectomy is the length of stay, which is the total time measured from day of surgery to the day of hospital discharge
Time frame: during hospital stay, an average of 4 days
Evaluation of the recruitment rate
The feasibility of this pilot study is assessed by means of the recruitment rate, defined by the number of eligible patients who are approached for participation and the percentage who consent to join the study over a specified time period. The recruitment rate is defined as excellent if 20 patients can be enrolled in this study in one year.
Time frame: during whole study period, an average of 1 year
Evaluation of the adherence rate
The feasibility of this pilot study is assessed by the adherence rate, which describes how well participants follow the study protocol including the prescribed interventions or follow-up assessments. The adherence rate is defined as excellent if ≥80% of the patients followed the study protocol including the prescribed interventions or follow-up assessments.
Time frame: during whole study period, an average of 1 year
Evaluation of medical costs
Evaluation of the potential changes in medical costs for the hospital and for the individual patient
Time frame: during study time of patient, an average of 3 months
Assessment of surgical fear
The short and long term surgical fear questionnaire will be evaluated at baseline, before the surgery. The short and long term questionnaire consist each of 4 questions, where 0 indicates no fear and 10 indicates extreme fear.
Time frame: At baseline
Quality of Life: EQ5D Questionnaire
Questionnaire measuring patients' general health and quality of life: EQ5D = EuroQol-5 Dimensions: mobility, self-care, daily activities, pain/discomfort, anxiety/depression. A score of 0 represent a very low quality of life, where score of 1 represents the maximum score.
Time frame: at baseline (day of surgery), Day7, Day28, Month3
Quality of Life: SF-36 Questionnaire
This questionnaire contains 36 questions and 8 dimensions: physical functioning, physical limitations, mental functioning, emotional limitations, social functioning, pain, general health, vitality. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: at baseline, Day 7, Day 28, Month 3
Evaluation of the technology acceptance questionnaire
Evaluation of the technology acceptance questionnaire, which contains 17 statements where patient can (completely) disagree, no opion or (completely) agree with.
Time frame: baseline
Pain scores (numerical rating scales)
Evaluation of different pain scores (abdominal pain, lower abdominal pain, pain at wound stitch hole, shoulder pain and pain after eating). These are numerical rating scales with 0 having no pain at all and 10 having extreme pain.
Time frame: 3 times per day for 10 days after the surgery
Satisfaction of patients
* Degree to which the patient is satisfied with the care pathway, felt safe during remote monitoring, and if they received sufficient information about the follow-up period. * Measured with Numeric Rating Scale (NRS), with 0 not satisfied at all and 10 extremely satisfied
Time frame: on day 10 after the surgery
Evaluation of pain medication
Assessment of the number of pain medication taken every day after the surgery
Time frame: daily up to 10 days after surgery
Evaluation of the acceptability of the remote care pathway
This wil be evaluated with a validated questionnaire containing 8 statements which the patient need to score as (completely) agree, no opinion or (completely) disagree
Time frame: on postoperative day 10
Evaluation of study patients admitted to the ICU
The number of patients admitted to the ICU after surgery will be assessed
Time frame: during study period, an average of 1 year
Evaluation of unplanned medical consultations or visits
Assessment of unplanned readmission rate and/or unscheduled home visits from a general practitioner or other medical doctor and/or emergency consultations
Time frame: during study period of the patient, an average of 3 months
Evaluation of post-operative complicatons
Assessment of post-operative complications associated with distal pancreatectomy
Time frame: during study period of the patient, an average of 3 months
Evaluation of respiratory rate
Assessment of the respiratory rate, defined in breaths per minute.
Time frame: during 10 days after surgery
Evaluation of the Intervention Appropriateness Measure
This wil be evaluated with a validated questionnaire containing 8 statements which the patient need to score as (completely) agree, no opinion or (completely) disagree
Time frame: on postoperative day 10
Evaluation of the Feasibility of Intervention Measure
This wil be evaluated with a validated questionnaire containing 8 statements which the patient need to score as (completely) agree, no opinion or (completely) disagree
Time frame: on postoperative day 10
Evaluation of temperature
Assessment of the temperature of the patient, defined in °C.
Time frame: during 10 days after surgery
Evaluation of oxygen saturation in blood
Assessment of oxygen saturation in blood, measured in %
Time frame: during 10 days after surgery
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Jessa Hospital