Health TrialsbyHealthPanel

Remote Clinical Monitoring After Robotic Distal Pancreatectomy

ConditionDigital Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJessa Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years old

Competent to provide informed consent

Fluent in Dutch

Cognitively capable of understanding and engaging with the study

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Remote clinical monitoring

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Remote clinical monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessa Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: