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Not Yet Recruiting NCT05610995

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

Conditions: Premature Exit After Colorectal Surgery

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 88
Sponsor: University Hospital, Grenoble

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:Age ≥ 18 yearsASA score 1-3Colonic or rectal resection with anastomosisMinimally invasive surgeryPatient living close to the hospital (<1 hour drive)Patient accompanied for 48 hoursBody Mass Index < 40Patient information and signature of consentPatient affiliated to a social insurance planA pregnancy test must be performed before inclusion in women of childbearing age.Non-inclusion Criteria:Socially isolated patient and/or no 3G cell signalSevere comorbidities defined as any of these characteristics:Severe malnutrition (albumin <30g/l)Severe anemia < 80 g/dlInsulin-dependent diabetes type 1e. Patient under anticoagulation f. Severe renal insufficiencyHistory of psychiatric illness with medication requirementsPersons 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)Patient not wishing to enter the studyPatient in a period of exclusion from another study or ongoing participation in an interventional studyExclusion Criteria:Stoma preparationPer operative conversion to laparotomyCHUNG score > 8

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05610995). StuddyBuddy aggregates publicly available trial information.