TerminatedNot Applicable

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

Stopped: recruitment faisibility

France6 participantsStarted 2023-07-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years
. ASA score 1-3
. Colonic or rectal resection with anastomosis
. Minimally invasive surgery
. Patient living close to the hospital (\<1 hour drive)
. Patient accompanied for 48 hours
. Body Mass Index \< 40
. Patient information and signature of consent

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05610995

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Premature Exit After Colorectal Surgery trials