CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Name Digital Solutionbehavioral
Likely dose
Not stated in record
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Search/NCT04153721
NCT04153721N/ACompleted

Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients

IHU Strasbourg·interventional·Posted Nov 6, 2019·Updated Feb 20, 2024

In Brief

A clinical study evaluating Name Digital Solution for Colorectal Cancer. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative). Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital. The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices. The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device. This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartMar 11, 2020
Primary CompletionMar 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.7 years ago

Interventions

Name Digital Solutionbehavioral

The digital solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption). In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team