Digital HealthTOTEMNCT06881602
Remote Clinical Monitoring After Robotic Distal Pancreatectomy
A study testing Remote clinical monitoring in people with Digital Health, run by Jessa Hospital.
Trial summary
This feasibility trial has three main objectives: To investigate the impact of the transmural care pathway TOTeM on the Length of Stay (LOS) for patients undergoing robotic distal pancreatectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digital Health
- What is being tested?
- Remote clinical monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Competent to provide informed consent
- Fluent in Dutch
- Cognitively capable of understanding and engaging with the study
- Undergoing robotic distal pancreatectomy
- Owing a smartphone or has a caregiver who can assist
- Does not live alone
- Have a valid national identification number
Who cannot join
- Extended left pancreatectomy
- Spleen-preserving procedure
- Residing in a nursing home
- Patients who are deemed unsuitable for the study by the physician based on clinical evaluation
- Absence of informed consent or request to not participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Remote Clinical Monitoring After Robotic Distal Pancreatectomy: a Pilot and Feasibility Study
This feasibility trial has three main objectives:
- To investigate the impact of the transmural care pathway TOTeM on the Length of Stay (LOS) for patients undergoing robotic distal pancreatectomy.
- To investigate the feasibility of the implementation of TOTeM for patients undergoing robotic distal pancreatic surgery, we will measure the recruitment rate by tracking the number of eligible patients who are approached for participation, the percentage who consent to join the study over a specified time period, and the adherence rate which describes how well participants follow the study protocol including the prescribed interventions or follow-up assessments.
- Assessment of the potential changes in medical costs and outcomes for the purpose of performing a cost-effectiveness analysis from a hospital and patient perspective.
Read the detailed description
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.
- Conditions
- Digital Health
- Being tested
- Remote clinical monitoring
- Keywords
- Remote monitoring, Pancreatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote clinical monitoringProcedure or surgery
Patients after a distal pancreatectomy will be discharged faster from the hospital and will be remote monitored
| Study group | Role | What they receive |
|---|---|---|
| Remote clinical monitoring | Experimental | The application of remote clinical monitoring after a distal robotic pancreatectomy Receives: Procedure: Remote clinical monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during hospital stay, an average of 4 days
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: on day 10 after the surgery
Evaluation of pain medication
Assessment of the number of pain medication taken every day after the surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: on postoperative day 10
Evaluation of temperature
Assessment of the temperature of the patient, defined in °C.
Measured: during 10 days after surgery
Evaluation of oxygen saturation in blood
Assessment of oxygen saturation in blood, measured in %
Measured: during 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881602
- Sponsor's protocol ID
- 2025/012
- Acronym
- TOTEM
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Clinical Monitoring After Robotic Distal Pancreatectomy: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06881602
- Acronym / sponsor ID
- TOTEM / 2025/012
- Conditions
- Digital Health
- Keywords
- Remote monitoring, Pancreatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility trial has three main objectives:
- To investigate the impact of the transmural care pathway TOTeM on the Length of Stay (LOS) for patients undergoing robotic distal pancreatectomy.
- To investigate the feasibility of the implementation of TOTeM for patients undergoing robotic distal pancreatic surgery, we will measure the recruitment rate by tracking the number of eligible patients who are approached for participation, the percentage who consent to join the study over a specified time period, and the adherence rate which describes how well participants follow the study protocol including the prescribed interventions or follow-up assessments.
- Assessment of the potential changes in medical costs and outcomes for the purpose of performing a cost-effectiveness analysis from a hospital and patient perspective.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote clinical monitoring | Experimental | Procedure: Remote clinical monitoringThe application of remote clinical monitoring after a distal robotic pancreatectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years old
- Competent to provide informed consent
- Fluent in Dutch
- Cognitively capable of understanding and engaging with the study
- Undergoing robotic distal pancreatectomy
Key exclusion criteria (5 listed)
- Extended left pancreatectomy
- Spleen-preserving procedure
- Residing in a nursing home
- Patients who are deemed unsuitable for the study by the physician based on clinical evaluation
- Absence of informed consent or request to not participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote clinical monitoringPatients after a distal pancreatectomy will be discharged faster from the hospital and will be remote monitored | Procedure or surgery | Remote clinical monitoring |
Primary outcome
Length of stay in hospital
Time frame: during hospital stay, an average of 4 days
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
19 secondary outcomes
Evaluation of the recruitment rate
Time frame: during whole study period, an average of 1 year
Evaluation of the adherence rate
Time frame: during whole study period, an average of 1 year
Evaluation of medical costs
Time frame: during study time of patient, an average of 3 months
Assessment of surgical fear
Time frame: At baseline
Quality of Life: EQ5D Questionnaire
Time frame: at baseline (day of surgery), Day7, Day28, Month3
Quality of Life: SF-36 Questionnaire
Time frame: at baseline, Day 7, Day 28, Month 3
Evaluation of the technology acceptance questionnaire
Time frame: baseline
Pain scores (numerical rating scales)
Time frame: 3 times per day for 10 days after the surgery
Satisfaction of patients
Time frame: on day 10 after the surgery
Evaluation of pain medication
Time frame: daily up to 10 days after surgery
Evaluation of the acceptability of the remote care pathway
Time frame: on postoperative day 10
Evaluation of study patients admitted to the ICU
Time frame: during study period, an average of 1 year
Evaluation of unplanned medical consultations or visits
Time frame: during study period of the patient, an average of 3 months
Evaluation of post-operative complicatons
Time frame: during study period of the patient, an average of 3 months
Evaluation of respiratory rate
Time frame: during 10 days after surgery
Evaluation of the Intervention Appropriateness Measure
Time frame: on postoperative day 10
Evaluation of the Feasibility of Intervention Measure
Time frame: on postoperative day 10
Evaluation of temperature
Time frame: during 10 days after surgery
Evaluation of oxygen saturation in blood
Time frame: during 10 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Remote clinical monitoring in people with Digital Health, run by Jessa Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bjorn Stessel, MD, PhD (+3211222107, bjorn.stessel@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in hospital (time frame: during hospital stay, an average of 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.