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

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.

Study Overview

• Status: Unknown
• Conditions: Mesh Augmentation
• Intervention / Treatment: Procedure: PPAWI

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
    • Principal Investigator: Filip Muysoms, MD, PhD
    • Contact: Iris Kyle-Leinhase, PhD; Phone Number: 003292467451; Email: iris.kyle-leinhase@azmmsj.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

11 patients were already operated by Dr. Filip Muysoms and Dr. Rudolf Vertriest

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PPAWI; patients with multidisciplinary PPAWI approach	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic result	Aesthetic result evaluated by physical examination	more than 12 months post-operatively
Quality of Life score	Quality of Life score assessment with the EuraHS QoL score	more than 12 months post-operatively

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Filip Muysoms, MD, PhD, Maria Middelares Hospital; Study Chair: Fien Decuypere, MD, Maria Middelares Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: mesh; abdominoplasty; rectus diastasis; panniculectomy
• Other Study ID Numbers: PPAWI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No