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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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
    4. 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 details

Premature Exit After Colorectal Surgery

NCT05610995

University Hospital, Grenoble

25 January 2024

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