Donor Site ComplicationNCT03209167
Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
An observational study of Donor Site Complication and Satisfaction, Personal, run by Oslo University Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Donor Site Complication, Satisfaction, Personal, Breast Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2001to 31 Dec 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Who may be able to join
- unilateral DIEAP flap, abdominoplasty
Who cannot join
- bilateral DIEAP flap, progressive cancer disease
About this study
The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.
Read the 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.
- Being tested
- Questionnaire
- Keywords
- Breast reconstruction; abdominoplasty; patient satisfaction
- Medical subject headings
- Personal Satisfaction, Breast Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Two study-specific questionnaires
| Study group | Role | What they receive |
|---|---|---|
| DIEAP group | Patients who had undergone DIEAP flap breast reconstruction Receives: Behavioral: Questionnaire | |
| AP group | Patients who had undergone conventional abdominoplasty Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2001 to 2004.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Jan 2001
- Primary completion31 Dec 2004
- Study completion31 Dec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor Site ComplicationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Alexander Tønseth, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209167
- Sponsor's protocol ID
- OsloPlastic
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
- ClinicalTrials.gov ID
- NCT03209167
- Acronym / sponsor ID
- OsloPlastic
- Keywords
- Breast reconstruction; abdominoplasty; patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2001 (actual)
- Primary completion
- 31 Dec 2004 (actual)
- Study completion
- 31 Dec 2004 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIEAP group | – | Behavioral: QuestionnairePatients who had undergone DIEAP flap breast reconstruction |
| AP group | – | Behavioral: QuestionnairePatients who had undergone conventional abdominoplasty |
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral DIEAP flap, abdominoplasty
Key exclusion criteria (1 listed)
- bilateral DIEAP flap, progressive cancer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTwo study-specific questionnaires | Behavioural | AP group, DIEAP group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor Site Complication and Satisfaction, Personal, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing patient satisfaction of the abdomen after DIEAP procedure and conventional abdominoplasty (time frame: 2001 to 2004.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.