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

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ClinicalTrials.gov Identifier: NCT03100669
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment
Postoperative Pain Postoperative Nausea 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Weeks
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
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain [ Time Frame: 10 weeks after surgery ]
    pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients planned for elective pectus surgery are asked for study inclusion.
Criteria

Inclusion Criteria:

  • elective pectus repair
  • signed informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100669


Contacts
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Contact: Davina Wildemeersch, MD 0032 038215891 davina.wildemeersch@uza.be
Contact: Guy Hans, MD, PhD 0032 038213586 guy.hans@uza.be

Locations
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Belgium
University hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Davina Wildemeersch, MD    03 821 58 91 ext 0032    davina.wildemeersch@uza.be   
Principal Investigator: Davina Wildemeersch, MD         
Principal Investigator: Michiel D'Hondt, MD         
Principal Investigator: Pieter Mertens, MD         
Principal Investigator: Guy Hans, MD, PhD         
Principal Investigator: Vera Saldien, MD         
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Davina Wildemeersch, Resident anesthesiology, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03100669     History of Changes
Other Study ID Numbers: 17/08/082
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Nausea
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Vomiting