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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2012 by University of Aarhus.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01329120

First received: April 4, 2011

Last updated: May 31, 2015

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 4, 2011

Last Updated Date

May 31, 2015

Start Date ^ICMJE

September 2015

Estimated Primary Completion Date

December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Persistent post-surgical pain [ Time Frame: At least 4 months following surgery ]

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01329120 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Health related quality of life [ Time Frame: At least 4 months following surgery ]
Health-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 satisfaction [ Time Frame: At least 4 months following surgery ]
Satisfaction 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 outcome [ Time Frame: At least 4 months following surgery ]
In 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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Pain, Postoperative

Intervention ^ICMJE

Procedure: Minimally invasive repair of pectus excavatum
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

Other Name: Nuss procedure
Procedure: Open surgical repair of pectus carinatum
Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum

Other Name: Ravitch procedure

Study Groups/Cohorts

Pectus excavatum
Patients who has undergone minimally invasive repair of pectus excavatum

Intervention: Procedure: Minimally invasive repair of pectus excavatum
Pectus carinatum
Patients who has undergone open surgical repair of pectus carinatum

Intervention: Procedure: Open surgical repair of pectus carinatum

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

7 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Denmark

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01329120

Other Study ID Numbers ^ICMJE

MIRPEX-1

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Kasper Grosen, PhD Fellow	Aarhus University Hospital Skejby
Study Director:	Hans K Pilegaard, MD	Aarhus University Hospital Skejby
Study Chair:	Mogens Pfeiffer-Jensen, MD, PhD	Aarhus University Hospital, Aarhus Sygehus
Study Chair:	Vibeke E Hjortdal, Prof., MD, PhD	Aarhus University Hospital Skejby

PRS Account

University of Aarhus

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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