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Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209167
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kim Alexander Tønseth, Oslo University Hospital

Brief Summary:
The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.

Condition or disease Intervention/treatment
Donor Site Complication Satisfaction, Personal Breast Cancer Behavioral: Questionnaire

Detailed Description:
34 patients reconstructed with a DIEAP flap (DIEAP group) and 30 patients who had undergone a conventional abdominoplasty (AP group) were asked to complete two study-specific questionnaires. One questionnaire covered general and specific aspects concerning abdominal outcomes and morbidity. The other covered general outcomes such as satisfaction with surgery and change of body image, self-confidence, social and intimate relations. In addition, all patients performed an abdominal muscle function test.

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Study Type : Observational
Enrollment : 44 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
Actual Study Start Date : January 1, 2001
Actual Primary Completion Date : December 31, 2004
Actual Study Completion Date : December 31, 2004

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
DIEAP group
Patients who had undergone DIEAP flap breast reconstruction
Behavioral: Questionnaire
Two study-specific questionnaires

AP group
Patients who had undergone conventional abdominoplasty
Behavioral: Questionnaire
Two study-specific questionnaires




Primary Outcome Measures :
  1. Comparing patient satisfaction of the abdomen after DIEAP procedure and conventional abdominoplasty [ Time Frame: 2001 to 2004. ]
    The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Criteria

Inclusion Criteria:

  • unilateral DIEAP flap, abdominoplasty

Exclusion Criteria:

  • bilateral DIEAP flap, progressive cancer disease
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Responsible Party: Kim Alexander Tønseth, Head of division, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03209167    
Other Study ID Numbers: OsloPlastic
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kim Alexander Tønseth, Oslo University Hospital:
Breast reconstruction; abdominoplasty; patient satisfaction