Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency

NCT ID: NCT02950194

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Mesh Augmentation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PPAWI

patients with multidisciplinary PPAWI approach

PPAWI

Intervention Type PROCEDURE

One-step procedure of a panniculectomy performed by a plastic surgeon together with a mesh augmentation of the abdominal wall by a general surgeon.

Interventions

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PPAWI

One-step procedure of a panniculectomy performed by a plastic surgeon together with a mesh augmentation of the abdominal wall by a general surgeon.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* No Informed Consent
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role lead

Responsible Party

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Filip Muysoms

surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip Muysoms, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maria Middelares hospital

Fien Decuypere, MD

Role: STUDY_CHAIR

Maria Middelares hospital

Locations

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AZ Maria Middelares

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Filip Muysoms, MD, PhD

Role: CONTACT

003292467416

Iris Kyle-Leinhase, PhD

Role: CONTACT

003292467451

Facility Contacts

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Iris Kyle-Leinhase, PhD

Role: primary

003292467451

Other Identifiers

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PPAWI

Identifier Type: -

Identifier Source: org_study_id

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