Remote Clinical Monitoring After Robotic Distal Pancreatectomy

NCT06881602 | Not Yet Recruiting

• 1 other identifier: 2025/012
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Digital Health

Keywords

Remote monitoring; Pancreatectomy

Outcome Measures

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

  during hospital stay, an average of 4 days

Secondary Outcomes (19)

• Evaluation of the recruitment rate

  during whole study period, an average of 1 year

• Evaluation of the adherence rate

  during whole study period, an average of 1 year

• Evaluation of medical costs

  during study time of patient, an average of 3 months

• Assessment of surgical fear

  At baseline

• Quality of Life: EQ5D Questionnaire

  at baseline (day of surgery), Day7, Day28, Month3

Study Arms (1)

Remote clinical monitoring

EXPERIMENTAL

The application of remote clinical monitoring after a distal robotic pancreatectomy

Procedure: Remote clinical monitoring

Interventions

Remote clinical monitoring PROCEDURE

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

Remote clinical monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Central Study Contacts

Bjorn Stessel, MD, PhD

CONTACT

+3211222107; bjorn.stessel@jessazh.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09