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

• Conditions: Mesh Augmentation
• Interventions: Procedure: PPAWI

• Registration Number: NCT02950194
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-11-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• No Informed Consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PPAWI	PPAWI	patients with multidisciplinary PPAWI approach

Primary Outcome Measures

Name	Time	Method
Evaluation of the rectus diastasis by ultrasound	more than 12 months post-operatively	Evaluation of the rectus diastasis after abdominoplasty with mesh augmentation using ultrasound at least 12 months post-operatively

Secondary Outcome Measures

Name	Time	Method
Aesthetic result	more than 12 months post-operatively	Aesthetic result evaluated by physical examination
Quality of Life score	more than 12 months post-operatively	Quality of Life score assessment with the EuraHS QoL score

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Ghent, Belgium