Skip to content

Remote Clinical Monitoring After Robotic Distal Pancreatectomy

Remote Clinical Monitoring After Robotic Distal Pancreatectomy: a Pilot and Feasibility Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06881602
Acronym
TOTEM
Enrollment
20
Registered
2025-03-18
Start date
2025-10-01
Completion date
2027-12-31
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital Health

Keywords

Remote monitoring, Pancreatectomy

Brief 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. * 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.

Interventions

Patients after a distal pancreatectomy will be discharged faster from the hospital and will be remote monitored

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Length of stay in hospitalduring hospital stay, an average of 4 daysThe 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

Secondary

MeasureTime frameDescription
Evaluation of the adherence rateduring whole study period, an average of 1 yearThe 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.
Evaluation of medical costsduring study time of patient, an average of 3 monthsEvaluation of the potential changes in medical costs for the hospital and for the individual patient
Assessment of surgical fearAt baselineThe 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.
Quality of Life: EQ5D Questionnaireat baseline (day of surgery), Day7, Day28, Month3Questionnaire 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.
Quality of Life: SF-36 Questionnaireat baseline, Day 7, Day 28, Month 3This 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.
Evaluation of the technology acceptance questionnairebaselineEvaluation of the technology acceptance questionnaire, which contains 17 statements where patient can (completely) disagree, no opion or (completely) agree with.
Pain scores (numerical rating scales)3 times per day for 10 days after the surgeryEvaluation 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.
Satisfaction of patientson day 10 after the surgery* 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
Evaluation of pain medicationdaily up to 10 days after surgeryAssessment of the number of pain medication taken every day after the surgery
Evaluation of the recruitment rateduring whole study period, an average of 1 yearThe 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.
Evaluation of study patients admitted to the ICUduring study period, an average of 1 yearThe number of patients admitted to the ICU after surgery will be assessed
Evaluation of unplanned medical consultations or visitsduring study period of the patient, an average of 3 monthsAssessment of unplanned readmission rate and/or unscheduled home visits from a general practitioner or other medical doctor and/or emergency consultations
Evaluation of post-operative complicatonsduring study period of the patient, an average of 3 monthsAssessment of post-operative complications associated with distal pancreatectomy
Evaluation of respiratory rateduring 10 days after surgeryAssessment of the respiratory rate, defined in breaths per minute.
Evaluation of the Intervention Appropriateness Measureon postoperative day 10This wil be evaluated with a validated questionnaire containing 8 statements which the patient need to score as (completely) agree, no opinion or (completely) disagree
Evaluation of the Feasibility of Intervention Measureon postoperative day 10This wil be evaluated with a validated questionnaire containing 8 statements which the patient need to score as (completely) agree, no opinion or (completely) disagree
Evaluation of temperatureduring 10 days after surgeryAssessment of the temperature of the patient, defined in °C.
Evaluation of oxygen saturation in bloodduring 10 days after surgeryAssessment of oxygen saturation in blood, measured in %
Evaluation of the acceptability of the remote care pathwayon postoperative day 10This wil be evaluated with a validated questionnaire containing 8 statements which the patient need to score as (completely) agree, no opinion or (completely) disagree

Contacts

Primary ContactBjorn Stessel, MD, PhD
bjorn.stessel@jessazh.be+3211222107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026