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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Postoperative Nausea
• Intervention / Treatment: Procedure: Pectus surgery

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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients planned for elective pectus surgery are asked for study inclusion.

Description

Inclusion Criteria:

• elective pectus repair
• signed informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pectus surgery; Single arm study: patient undergoing pectus repair surgery	Procedure: Pectus surgery; Patients undergoing surgical repair of pectus excavatum or carinatum

What is the study measuring?

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)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Vomiting; Nausea; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 17/08/082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No