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NCT Number: NCT03100669

Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program 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.

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Key information

Conditions

Postoperative Pain Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective pectus repair
  • signed informed consent

Exclusion criteria

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

Treatment and study plan

Pectus surgery

Procedure

Patients undergoing surgical repair of pectus excavatum or carinatum

Primary outcomes

  1. Pain

    Time frame: 10 weeks after surgery

    pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery

Secondary outcomes

  1. Sleep

    Time frame: 2 weeks before up to 10 weeks after surgery

    hours of sleep up to 10 weeks after surgery

  2. Daily activity

    Time frame: 2 weeks before up to 10 weeks after surgery

    daily activity via scale (0: no activity and 10 maximum of activities) and activity tracker device during hospitalization up to 10 weeks after surgery

  3. Nausea

    Time frame: From day of surgery until hospital discharge (approximately 7 days)

    registration of nausea and vomiting by questionnaire during hospitalization period

  4. Mobility

    Time frame: From 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 outcomes

  1. Rosenberg self-esteem questionnaire

    Time frame: Allowed period for fill in: from two weeks before planned surgery until day before planned surgery

    Preoperative evaluation of self-esteem by the Rosenberg self-esteem questionnaire, via a patient specific online platform

  2. Hospital anxiety and depression scale (HAD)

    Time frame: Allowed period for fill in: from two weeks before planned surgery until day before planned surgery

    Preoperative evaluation of anxiety and depression by the HAD questionnaire, via a patient specific online platform

  3. State-Trait anxiety Inventory (STAI)

    Time frame: Allowed period for fill in: from two weeks before planned surgery until day before planned surgery

    Preoperative evaluation of state and trait characteristics by the STAI questionnaire, via a patient specific online platform

  4. Multidisciplinary Pain Inventory (MPI)

    Time frame: Allowed period for fill in: first two weeks after hospital discharge

    Postoperative evaluation of pain severity and interference by the MPI questionnaire, via a patient specific online platform

  5. Coping Pain Questionnaire (CPQ)

    Time frame: Allowed period for fill in: first two weeks after hospital discharge

    Postoperative evaluation of coping strategy (active, passive, self-efficacy) by the CPQ questionnaire, via a patient specific online platform

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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