Clinical trial NCT06881602: Remote Clinical Monitoring After Robotic Distal Pancreatectomy
Official title: Remote Clinical Monitoring After Robotic Distal Pancreatectomy: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Digital Health
Keywords: Remote monitoring
Pancreatectomy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Length of stay in hospital
timeFrame: during hospital stay, an average of 4 days
Secondary outcomes:
measure: Evaluation of the recruitment rate
timeFrame: during whole study period, an average of 1 year
measure: Evaluation of the adherence rate
timeFrame: during whole study period, an average of 1 year
measure: Evaluation of medical costs
timeFrame: during study time of patient, an average of 3 months
measure: Assessment of surgical fear
timeFrame: At baseline
measure: Quality of Life: EQ5D Questionnaire
timeFrame: at baseline (day of surgery), Day7, Day28, Month3
measure: Quality of Life: SF-36 Questionnaire
timeFrame: at baseline, Day 7, Day 28, Month 3
measure: Evaluation of the technology acceptance questionnaire
timeFrame: baseline
measure: Pain scores (numerical rating scales)
timeFrame: 3 times per day for 10 days after the surgery
measure: Satisfaction of patients
timeFrame: on day 10 after the surgery
measure: Evaluation of pain medication
timeFrame: daily up to 10 days after surgery
measure: Evaluation of the acceptability of the remote care pathway
timeFrame: on postoperative day 10
measure: Evaluation of study patients admitted to the ICU
timeFrame: during study period, an average of 1 year
measure: Evaluation of unplanned medical consultations or visits
timeFrame: during study period of the patient, an average of 3 months
measure: Evaluation of post-operative complicatons
timeFrame: during study period of the patient, an average of 3 months
measure: Evaluation of respiratory rate
timeFrame: during 10 days after surgery
measure: Evaluation of the Intervention Appropriateness Measure
timeFrame: on postoperative day 10
measure: Evaluation of the Feasibility of Intervention Measure
timeFrame: on postoperative day 10
measure: Evaluation of temperature
timeFrame: during 10 days after surgery
measure: Evaluation of oxygen saturation in blood
timeFrame: during 10 days after surgery
Other outcomes:
Locations:
Study officials:
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