Remote Clinical Monitoring After Robotic Distal Pancreatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote clinical monitoring.
- Who it may be relevant to
- Registry conditions: Digital Health. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote Clinical Monitoring After Robotic Distal Pancreatectomy: a Pilot and Feasibility Study
Overview
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
- Procedure Remote clinical monitoring
Patients after a distal pancreatectomy will be discharged faster from the hospital and will be remote monitored
Primary outcome measures
- Length of stay in hospital [Time frame: during hospital stay, an average of 4 days]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06881602 · 2025/012