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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100669
• Other study ID #: 17/08/082
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• elective pectus repair

• signed informed consent

Exclusion Criteria:

• chronic opioid use (> 3 months)

• history of ongoing psychiatric disease

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Procedure:
• Pectus surgery
Patients undergoing surgical repair of pectus excavatum or carinatum

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Pain	pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery	10 weeks after surgery
Secondary	Sleep	hours of sleep up to 10 weeks after surgery	2 weeks before up to 10 weeks after surgery
Secondary	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
Secondary	Nausea	registration of nausea and vomiting by questionnaire during hospitalization period	From day of surgery until hospital discharge (approximately 7 days)
Secondary	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)