Short and Long-term Effects of Surgical Repair of Pectus Deformities

NCT01329120 | Unknown

• 1 other identifier: MIRPEX-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A large number of institutions have reported their early results with minimally invasive repair of pectus excavatum and open repair of pectus carinatum, but only few have addressed the outcomes relevant to the concerns of the patients and even fewer have reported long-term results following bar removal. Even fewer studies have investigated the prevalence and characteristics of long term persistent post-surgical pain following surgical repair of pectus deformities. The reasons as to why acute postoperative pain in some patients persists and becomes chronic whereas in others the pain dies down shortly after wound healing are largely unknown, and why some patients complain of loss of sensibility in wide regions of their chest following surgery also remains unclear.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Persistent post-surgical pain

  Persistent post-surgical pain is in this study defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection and malignancy) and pain continuing from a pre-existing pain problem will be excluded. Persistent post-surgical pain present at time of the study will be assessed by means of a specifically developed questionnaire including items from the Danish translation of the Brief Pain inventory (BPI-short form) and the Danish translation of the short version of the McGill Pain Questionnaire (SF-MPQ).

  At least 4 months following surgery

Secondary Outcomes (3)

• Health related quality of life

  At least 4 months following surgery

• Patient satisfaction

  At least 4 months following surgery

• Aesthetic outcome

  At least 4 months following surgery

Study Arms (2)

Pectus excavatum

Patients who has undergone minimally invasive repair of pectus excavatum

Procedure: Minimally invasive repair of pectus excavatum

Pectus carinatum

Patients who has undergone open surgical repair of pectus carinatum

Procedure: Open surgical repair of pectus carinatum

Interventions

Minimally invasive repair of pectus excavatum PROCEDURE

Minimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall

Also known as: Nuss procedure

Pectus excavatum

Open surgical repair of pectus carinatum PROCEDURE

Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum

Also known as: Ravitch procedure

Pectus carinatum

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients referred to the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby for the purpose of pectus deformity repair from January 1, 2001 to December 31, 2010 are invited to participate in the study.

You may qualify if:

• Minimally invasive repair of pectus excavatum from 2001 throughout 2010.
• Open surgical repair of pectus carinatum from 2001 throughout 2010.

You may not qualify if:

• Not being able to fill in detailed questionnaires in Danish

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, Skejby, Department of Cardiothoracic and Vascular Surgery

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Kasper Grosen, PhD Fellow

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

• Hans K Pilegaard, MD

  Aarhus University Hospital Skejby

  STUDY DIRECTOR

• Mogens Pfeiffer-Jensen, MD, PhD

  Aarhus University Hospital, Aarhus Sygehus

  STUDY CHAIR

• Vibeke E Hjortdal, Prof., MD, PhD

  Aarhus University Hospital Skejby

  STUDY CHAIR

Central Study Contacts

Kasper Grosen, PhD Fellow

CONTACT

+4589495443; kasper.grosen@ki.au.dk

Hans K Pilegaard, MD

CONTACT

+4589495403; pilegaard@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 5, 2011
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2012-06

Locations

DK (1)