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

Not Applicable

Recruiting

• Conditions: Premature Exit After Colorectal Surgery
• Interventions: Device: SENSIUM Patch

• Registration Number: NCT05610995
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-09
• Status Verified: 2023-07
• Study Start: 2023-07-22
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SENSIUM Group	SENSIUM Patch	Patients in the experimental group will be discharged with the device after an assessment on Day 1.

Primary Outcome Measures

Name	Time	Method
Evaluating the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis	at Day 30	Overall length of stay of the patient (index stay, and possible re-hospitalizations)

Secondary Outcome Measures

Name	Time	Method
Evaluate the evolution of vital parameters	To Day 1 at the end of study	Trend analysis of vital parameters
Evaluate the rate of re-hospitalization performed	To the post-surgical hospital discharge at Day 30	Presence of a rehospitalization between the post-surgical hospital discharge and Day 30
Assess transit recovery	at Day 1	Time of resumption of transit formalized by the resumption of gas, the time being calculated between the closure of the skin and the first gas in hours
Assess pain	at Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 and Day 30	Pain, by visual analog scale (0-10)
Assess opioid use	at Day 5	5-day opioid consumption rate
Evaluate the complication rate	at Day 30 according to the postoperative management performed	Presence of a complication according to the Clavien Dindo classification
Evaluate the cost of care	To Day 1 at the end of study	Cost analysis (hospitalizations, consultations, re-interventions, time off work, transportation and SENSIUM system costs)
Assess the rate of unscheduled visits	at Day 30	Presence of an unscheduled consultation at Day 30 post-surgery
Assess the patient's quality of life and overall satisfaction	at Day 30	EuroQol 5D 3L standardized scale score (overall satisfaction) at pre-inclusion, Day 1, Day 5 and Day 30 post-surgery visit

Trial Locations

Locations (7)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU Angers; 🇫🇷 Angers, France

Clinique TIVOLI; 🇫🇷 Bordeaux, France

Chru Brest; 🇫🇷 Brest, France

Chu Amiens; 🇫🇷 Amiens, France

Chu Nantes; 🇫🇷 Nantes, France