Short and Long-term Effects of Surgical Repair of Pectus Deformities
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ClinicalTrials.gov Identifier: NCT01329120 |
Recruitment Status
: Unknown
Verified June 2012 by University of Aarhus.
Recruitment status was: Not yet recruiting
First Posted
: April 5, 2011
Last Update Posted
: June 2, 2015
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Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
Tracking Information | |||||||||||||
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First Submitted Date | April 4, 2011 | ||||||||||||
First Posted Date | April 5, 2011 | ||||||||||||
Last Update Posted Date | June 2, 2015 | ||||||||||||
Study Start Date | September 2015 | ||||||||||||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures |
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). |
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Original Primary Outcome Measures | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT01329120 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||||||
Current Other Outcome Measures | Not Provided | ||||||||||||
Original Other Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title | Short and Long-term Effects of Surgical Repair of Pectus Deformities | ||||||||||||
Official Title | 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 | Observational | ||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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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 | Pain, Postoperative | ||||||||||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status | Unknown status | ||||||||||||
Estimated Enrollment |
1000 | ||||||||||||
Original Estimated Enrollment | Same as current | ||||||||||||
Estimated Study Completion Date | December 2015 | ||||||||||||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 7 Years and older (Child, Adult, Senior) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries | Denmark | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT01329120 | ||||||||||||
Other Study ID Numbers | MIRPEX-1 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | University of Aarhus | ||||||||||||
Study Sponsor | University of Aarhus | ||||||||||||
Collaborators | Not Provided | ||||||||||||
Investigators |
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PRS Account | University of Aarhus | ||||||||||||
Verification Date | June 2012 |