Clinical trial NCT05610995: Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device
Official title: Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Exit After Colorectal Surgery
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized, two-arm, parallel, open-label, interventional controlled trial with masked outcome assessment (PROBE design)
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluating the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis
timeFrame: at Day 30
Secondary outcomes:
measure: Assess transit recovery
timeFrame: at Day 1
measure: Assess pain
timeFrame: at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30
measure: Assess opioid use
timeFrame: at Day 5
measure: Evaluate the complication rate
timeFrame: at Day 30 according to the postoperative management performed
measure: Evaluate the rate of re-hospitalization performed
timeFrame: To the post-surgical hospital discharge at Day 30
measure: Assess the rate of unscheduled visits
timeFrame: at Day 30
measure: Assess the patient's quality of life and overall satisfaction
timeFrame: at Day 30
measure: Evaluate the cost of care
timeFrame: To Day 1 at the end of study
measure: Evaluate the evolution of vital parameters
timeFrame: To Day 1 at the end of study
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: Clinique TIVOLI
city: Brest
country: France
facility: Chru Brest
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: Chu Nantes
Study officials:
References: