Postoperative PainNCT03100669
Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring
An observational study of Postoperative Pain and Postoperative Nausea, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea
- What is being tested?
- Pectus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2017to 31 Dec 2019
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients planned for elective pectus surgery are asked for study inclusion.
Who may be able to join
- elective pectus repair
- signed informed consent
Who cannot join
- chronic opioid use (> 3 months)
- history of ongoing psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain, Postoperative Nausea
- Being tested
- Pectus surgery
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectus surgeryProcedure or surgery
Patients undergoing surgical repair of pectus excavatum or carinatum
| Study group | Role | What they receive |
|---|---|---|
| Pectus surgery | Single arm study: patient undergoing pectus repair surgery Receives: Procedure: Pectus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery
Measured: 10 weeks after surgery
Secondary outcomes (4)
Sleep
hours of sleep up to 10 weeks after surgery
Measured: 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
Measured: 2 weeks before up to 10 weeks after surgery
Nausea
registration of nausea and vomiting by questionnaire during hospitalization period
Measured: 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
Measured: From day of surgery until hospital discharge (approximately 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 May 2017
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100669
- Sponsor's protocol ID
- 17/08/082
- Status last verified
- Jan 2020
- First submitted
- 21 Mar 2017
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33401363Wildemeersch 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.
PubMed 29853436
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03100669
- Acronym / sponsor ID
- 17/08/082
- Conditions
- Postoperative Pain, Postoperative Nausea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pectus surgery | – | Procedure: Pectus surgerySingle arm study: patient undergoing pectus repair surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients planned for elective pectus surgery are asked for study inclusion.
Key inclusion criteria (2 listed)
- elective pectus repair
- signed informed consent
Key exclusion criteria (2 listed)
- chronic opioid use (> 3 months)
- history of ongoing psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pectus surgeryPatients undergoing surgical repair of pectus excavatum or carinatum | Procedure or surgery | Pectus surgery |
Primary outcome
Pain
Time frame: 10 weeks after surgery
pain registration via numeric rating scale during hospitalization up to 10 weeks after surgery
4 secondary outcomes
Sleep
Time frame: 2 weeks before up to 10 weeks after surgery
Daily activity
Time frame: 2 weeks before up to 10 weeks after surgery
Nausea
Time frame: From day of surgery until hospital discharge (approximately 7 days)
Mobility
Time frame: From day of surgery until hospital discharge (approximately 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 33401363Wildemeersch 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.
- Derived from this study: PubMed 29853436Wildemeersch 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.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Recruiting
Post Operative Pain and Vagal Stimulation
Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postoperative Nausea, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 10 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100669, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.