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

July 3, 2017 updated by: Kim Alexander Tønseth, Oslo University Hospital
The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment

44

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • unilateral DIEAP flap, abdominoplasty

Exclusion Criteria:

  • bilateral DIEAP flap, progressive cancer disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2001 to 2004.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2001

Primary Completion (Actual)

December 31, 2004

Study Completion (Actual)

December 31, 2004

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OsloPlastic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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