Skip to content

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

Short and Long-term Effects of Surgical Repair of Pectus Excavatum and Pectus Carinatum - A Questionnaire Study of Persistent Post-surgical Pain, Health-related Quality of Life, Patient Satisfaction, and Aesthetic Outcome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01329120
Enrollment
1000
Registered
2011-04-05
Start date
2015-09-30
Completion date
2015-12-31
Last updated
2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

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

PROCEDUREOpen surgical repair of pectus carinatum

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

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Not being able to fill in detailed questionnaires in Danish

Design outcomes

Primary

MeasureTime frameDescription
Persistent post-surgical painAt least 4 months following surgeryPersistent 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).

Secondary

MeasureTime frameDescription
Health related quality of lifeAt least 4 months following surgeryHealth-related quality of life (HRQol) will be assessed by means of a validated Danish version of the Short-Form (36) Health Survey (SF-36)
Patient satisfactionAt least 4 months following surgerySatisfaction with the result of the deformity repair and the perceived impact of the correction on health-related quality of life is assessed by means of questions about the emotional and practical consequences of, and satisfaction with pectus repair.
Aesthetic outcomeAt least 4 months following surgeryIn order to assess the surgical outcome following pectus repair in terms of aesthetic outcome more objectively, patients are encouraged to upload or e-mail a digital frontal image of their chests. Two thoracic surgeons, including the operating surgeon, and a research secretary are instructed to evaluate the breast symmetry, scars on the chest, and the overall cosmetic result of the repair.

Countries

Denmark

Contacts

Primary ContactKasper Grosen, PhD Fellow
kasper.grosen@ki.au.dk+4589495443
Backup ContactHans K Pilegaard, MD
pilegaard@dadlnet.dk+4589495403

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026