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

Mesh Augmentation Clinical Trial

— PPAWI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02950194
• Other study ID #: PPAWI
• Status: Recruiting
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Filip Muysoms, MD, PhD
• Phone: 003292467416
• Email: filip.muysoms[@]azmmsj.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

• No Informed Consent

Related Conditions & MeSH terms

• Mesh Augmentation

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Aesthetic result	Aesthetic result evaluated by physical examination	more than 12 months post-operatively
Secondary	Quality of Life score	Quality of Life score assessment with the EuraHS QoL score	more than 12 months post-operatively