Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring

Study Overview
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Brief Summary
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MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the patient. Surgery is often associated with severe postoperative pain. In this study the researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short and long term follow up.

Detailed Description
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In order to provide pain patients with an individualized approach to their pain problem after MIRP we developed an electronic medical record coupled to a set of telemetric medical-grade devices. Appi@Home (Antwerp Personalized Pain Initiative) supports an innovative approach to (sub)acute conditions by offering a platform for continuous follow-up. Patients are provided with a toolbox and an app that continuously collects objective outcome data (i.e. pain intensity, sleep quality, physical activity). The integrated system allows the care givers to respond very quickly to changing clinical conditions of the patient, making a very adaptive and individualized follow-up possible for these patients. In addition, the patient becomes an active participant in the global therapeutic approach. Patients receive the toolbox two week prior to surgery with access to the internet platform for questionnaires fill-in procedure. Up to ten week after surgery pain intensity, sleep quality and physical activity will be monitored subjectively by a scoring table (0-10, 0 no pain-bad sleeping quality-no activity, 10 maximum of pain-excellent sleeping quality- a lot of activity) and objectively by blood pressure device, oxygen saturation monitoring, activity tracker and sleep registration tool.

Official Title
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Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program: Short and Long-term Evaluation of Pain, Nausea, Sleep, and Rehabilitation Via Tele-monitoring

Conditions
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Postoperative Pain, Postoperative Nausea

Intervention / Treatment
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* Procedure: Pectus surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective pectus repair signed informed consent Exclusion Criteria: chronic opioid use (> 3 months) history of ongoing psychiatric disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pectus surgery<br>Single arm study: patient undergoing pectus repair surgery | Procedure: Pectus surgery<br>* Patients undergoing surgical repair of pectus excavatum or carinatum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery | 10 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | hours of sleep up to 10 weeks after surgery | 2 weeks before up to 10 weeks after surgery | 
| Daily activity | daily activity via scale (0: no activity and 10 maximum of activities) and activity tracker device during hospitalization up to 10 weeks after surgery | 2 weeks before up to 10 weeks after surgery | 
| Nausea | registration of nausea and vomiting by questionnaire during hospitalization period | From day of surgery until hospital discharge (approximately 7 days) | 
| Mobility | Daily mobility assessment by attending physiotherapist via scale (1: exercises in bed, 2: exercises while sitting, 3: exercises while standing, 4: exercises while walking) during hospitalization | From day of surgery until hospital discharge (approximately 7 days) |