Mesh Augmentation Clinical Trial
— PPAWIOfficial title:
Navel Sparing Retro-muscular Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency (PPAWI)
NCT number | NCT02950194 |
Other study ID # | PPAWI |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | December 2020 |
The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI (one-step procedure a panniculectomy by a plastic surgeon was performed together with a mesh augmentation of the abdominal wall by a general surgeon) at least 1 year post-operatively. Evaluation of the PPAWI approach by clinical examination with Quality of Life questionnaire and by ultrasound examination.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Adult female patients who underwent an abdominal wall repair and an abdominoplasty in one-step technique Exclusion Criteria: - Pregnancy - No Informed Consent |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Maria Middelares | Ghent |
Lead Sponsor | Collaborator |
---|---|
Algemeen Ziekenhuis Maria Middelares |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the rectus diastasis by ultrasound | Evaluation of the rectus diastasis after abdominoplasty with mesh augmentation using ultrasound at least 12 months post-operatively | more than 12 months post-operatively | |
Secondary | Aesthetic result | Aesthetic result evaluated by physical examination | more than 12 months post-operatively | |
Secondary | Quality of Life score | Quality of Life score assessment with the EuraHS QoL score | more than 12 months post-operatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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