Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device (Colo-SENSIUM)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Premature Exit After Colorectal Surgery

Treatments: Device: SENSIUM Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05610995

38RC21.0379

Details and patient eligibility

About

The principal aim of this study is to evaluate the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis.

The device SENSIUM is a tool to monitor vital signs (respiratory rate, heart rate and temperature) by applying a connected skin patch in order to detect complications early.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. ASA score 1-3
3. Colonic or rectal resection with anastomosis
4. Minimally invasive surgery
5. Patient living close to the hospital (<1 hour drive)
6. Patient accompanied for 48 hours
7. Body Mass Index < 40
8. Patient information and signature of consent
9. Patient affiliated to a social insurance plan
10. A pregnancy test must be performed before inclusion in women of childbearing age.

Non-inclusion Criteria:

1. Socially isolated patient and/or no 3G cell signal

2. Severe comorbidities defined as any of these characteristics:

   1. Severe malnutrition (albumin <30g/l)
   2. Severe anemia < 80 g/dl
   3. Insulin-dependent diabetes type 1

   e. Patient under anticoagulation f. Severe renal insufficiency

3. History of psychiatric illness with medication requirements

4. Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection)

5. Patient not wishing to enter the study

6. Patient in a period of exclusion from another study or ongoing participation in an interventional study

Exclusion criteria

1. Stoma preparation
2. Per operative conversion to laparotomy
3. CHUNG score > 8

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

SENSIUM Group

Experimental group

Description:

Patients in the experimental group will be discharged with the device after an assessment on Day 1.

Treatment:

Device: SENSIUM Patch

ERAS standard Group

No Intervention group

Description:

Patients in the control group will receive the usual ERAS (conventional hospitalization for clinicobiological monitoring).