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

NCT03100669 | Completed

• 1 other identifier: 17/08/082
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Nausea

Outcome Measures

Primary Outcomes (1)

• Pain

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

  10 weeks after surgery

Secondary Outcomes (4)

• Sleep

  2 weeks before up to 10 weeks after surgery

• Daily activity

  2 weeks before up to 10 weeks after surgery

• Nausea

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

• Mobility

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

Other Outcomes (5)

• Rosenberg self-esteem questionnaire

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

• Hospital anxiety and depression scale (HAD)

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

• State-Trait anxiety Inventory (STAI)

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

Study Arms (1)

Pectus surgery

Single arm study: patient undergoing pectus repair surgery

Procedure: Pectus surgery

Interventions

Pectus surgery PROCEDURE

Patients undergoing surgical repair of pectus excavatum or carinatum

Pectus surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• elective pectus repair
• signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (2)

• 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.

  PMID: 33401363 DERIVED

• 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.

  PMID: 29853436 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident anesthesiology

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 4, 2017
• Study Start: May 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)