Clinical trial NCT03100669: Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring
Official title: Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program: Short and Long-term Evaluation of Pain, Nausea, Sleep, and Rehabilitation Via Tele-monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Postoperative Nausea
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2017-04-04
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients planned for elective pectus surgery are asked for study inclusion.

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.

Eligibility criteria: Inclusion Criteria:

* elective pectus repair
* signed informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Pain
timeFrame: 10 weeks after surgery
Secondary outcomes:
measure: Sleep
timeFrame: 2 weeks before up to 10 weeks after surgery
measure: Daily activity
timeFrame: 2 weeks before up to 10 weeks after surgery
measure: Nausea
timeFrame: From day of surgery until hospital discharge (approximately 7 days)
measure: Mobility
timeFrame: From day of surgery until hospital discharge (approximately 7 days)
Other outcomes:
measure: Rosenberg self-esteem questionnaire
timeFrame: Allowed period for fill in: from two weeks before planned surgery until day before planned surgery
measure: Hospital anxiety and depression scale (HAD)
timeFrame: Allowed period for fill in: from two weeks before planned surgery until day before planned surgery
measure: State-Trait anxiety Inventory (STAI)
timeFrame: Allowed period for fill in: from two weeks before planned surgery until day before planned surgery
measure: Multidisciplinary Pain Inventory (MPI)
timeFrame: Allowed period for fill in: first two weeks after hospital discharge
measure: Coping Pain Questionnaire (CPQ)
timeFrame: Allowed period for fill in: first two weeks after hospital discharge
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
References:
citation: 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.
citation: 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. Erratum In: JMIR Ment Health. 2018 Nov 12;5(4):e11608. doi: 10.2196/11608.