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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03100669
Enrollment
47
Registered
2017-04-04
Start date
2017-05-01
Completion date
2019-12-31
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea, Postoperative Pain

Brief summary

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

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.

Interventions

PROCEDUREPectus surgery

Patients undergoing surgical repair of pectus excavatum or carinatum

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* elective pectus repair * signed informed consent

Exclusion criteria

* chronic opioid use (\> 3 months) * history of ongoing psychiatric disease

Design outcomes

Primary

MeasureTime frameDescription
Pain10 weeks after surgerypain registration via numeric rating scale during hospitalization up to 10 weeks after surgery

Secondary

MeasureTime frameDescription
Sleep2 weeks before up to 10 weeks after surgeryhours of sleep up to 10 weeks after surgery
Daily activity2 weeks before up to 10 weeks after surgerydaily activity via scale (0: no activity and 10 maximum of activities) and activity tracker device during hospitalization up to 10 weeks after surgery
NauseaFrom day of surgery until hospital discharge (approximately 7 days)registration of nausea and vomiting by questionnaire during hospitalization period
MobilityFrom day of surgery until hospital discharge (approximately 7 days)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

Other

MeasureTime frameDescription
Rosenberg self-esteem questionnaireAllowed period for fill in: from two weeks before planned surgery until day before planned surgeryPreoperative evaluation of self-esteem by the Rosenberg self-esteem questionnaire, via a patient specific online platform
Hospital anxiety and depression scale (HAD)Allowed period for fill in: from two weeks before planned surgery until day before planned surgeryPreoperative evaluation of anxiety and depression by the HAD questionnaire, via a patient specific online platform
State-Trait anxiety Inventory (STAI)Allowed period for fill in: from two weeks before planned surgery until day before planned surgeryPreoperative evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform
Multidisciplinary Pain Inventory (MPI)Allowed period for fill in: first two weeks after hospital dischargePostoperative evaluation of pain severity and interference by the MPI questionnaire, via a patient specific online platform
Coping Pain Questionnaire (CPQ)Allowed period for fill in: first two weeks after hospital dischargePostoperative evaluation of coping strategy (active, passive, self-efficacy) by the CPQ questionnaire, via a patient specific online platform

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026