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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209167
Other study ID # OsloPlastic
Secondary ID
Status Completed
Phase N/A
First received July 3, 2017
Last updated July 3, 2017
Start date January 1, 2001
Est. completion date December 31, 2004

Study information

Verified date July 2017
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 31, 2004
Est. primary completion date December 31, 2004
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- unilateral DIEAP flap, abdominoplasty

Exclusion Criteria:

- bilateral DIEAP flap, progressive cancer disease

Study Design


Intervention

Behavioral:
Questionnaire
Two study-specific questionnaires

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Comparing patient satisfaction of the abdomen after DIEAP procedure and conventional abdominoplasty The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty. 2001 to 2004.
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