Mesh Augmentation Clinical Trial
Official title:
Navel Sparing Retro-muscular Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency (PPAWI)
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.
PPAWI (post partum abdominal wall insufficiency) is an acronym first introduced during
Congress of the European Hernia Society in 2013. It is a pathological condition induced by
abdominal distension during pregnancy. General laxity of the anterior abdominal wall develops
because of diastasis of the rectus abdominis muscles and excess of skin and panniculus. This
has important repercussion on abdominal wall function and its aesthetics. This diastasis is
induced by abdominal distension and hormonal influences.
To evaluate diastasis of the rectus abdominis the inter-recti distance (IRD) is measured by
ultrasound. When it is 3cm or more, it is defined as diastasis of recti abdominis.
An operation is indicated when there is an aesthetic problem and/or the abdominal wall
function is impaired e.g. by loss of integrity of myofascial system and altered angle of
attachment, which results in loss of abdominal muscle strength and endurance and loss of
pelvic stabilization.
Since September 2013, 11 patients underwent an one-step procedure in which a panniculectomy/
abdominoplasty performed by a plastic surgeon was combined by a mesh augmentation of the
abdominal wall with a Parietex Progrip Self Fixating Mesh performed by a general surgeon in
the Maria Middelares hospital, Ghent, Belgium.
The study will be conducted in the department of surgery in the Maria Middelares hospital,
Ghent, Belgium. Dr. Filip Muysoms (general surgeon) selected all patient that have previous
been operated together with Dr. Rudolf Vertriest (plastic surgeon) with PPAWI technique.
Ultrasound will be performed by Dr. Beckers subsequently pre- and postoperative. Pictures to
evaluate the esthetic result will be taken by Dr. Vertriest pre- and postoperative.
The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI at
least one year post-operatively by clinical and radiological examination.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06050161 -
Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery
|
N/A |