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

NCT ID: NCT03100669

Last Updated: 2020-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-12-31

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.

Conditions

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Postoperative Pain Postoperative Nausea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pectus surgery

Single arm study: patient undergoing pectus repair surgery

Pectus surgery

Intervention Type PROCEDURE

Patients undergoing surgical repair of pectus excavatum or carinatum

Interventions

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Pectus surgery

Patients undergoing surgical repair of pectus excavatum or carinatum

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Davina Wildemeersch

Resident anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital Antwerp

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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Wildemeersch D, D'Hondt M, Bernaerts L, Mertens P, Saldien V, Hendriks JM, Walcarius AS, Sterkens L, Hans GH. Implementation of an Enhanced Recovery Pathway for Minimally Invasive Pectus Surgery: A Population-Based Cohort Study Evaluating Short- and Long-Term Outcomes Using eHealth Technology. JMIR Perioper Med. 2018 Oct 12;1(2):e10996. doi: 10.2196/10996.

Reference Type DERIVED
PMID: 33401363 (View on PubMed)

Wildemeersch D, Bernaerts L, D'Hondt M, Hans G. Preliminary Evaluation of a Web-Based Psychological Screening Tool in Adolescents Undergoing Minimally Invasive Pectus Surgery: Single-Center Observational Cohort Study. JMIR Ment Health. 2018 May 31;5(2):e45. doi: 10.2196/mental.9806.

Reference Type DERIVED
PMID: 29853436 (View on PubMed)

Other Identifiers

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17/08/082

Identifier Type: -

Identifier Source: org_study_id

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