Clinical trial NCT02950194: Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency
Official title: Navel Sparing Retro-muscular Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency (PPAWI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mesh Augmentation
Keywords: mesh
rectus diastasis
panniculectomy
abdominoplasty
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 11 patients were already operated by Dr. Filip Muysoms and Dr. Rudolf Vertriest

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult female patients who underwent an abdominal wall repair and an abdominoplasty in one-step technique

Exclusion Criteria:

* Pregnancy
* No Informed Consent

Primary outcomes:
measure: Evaluation of the rectus diastasis by ultrasound
timeFrame: more than 12 months post-operatively
Secondary outcomes:
measure: Aesthetic result
timeFrame: more than 12 months post-operatively
measure: Quality of Life score
timeFrame: more than 12 months post-operatively
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Maria Middelares hospital
name: Filip Muysoms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maria Middelares hospital
name: Fien Decuypere, MD
role: STUDY_CHAIR
References: