NCT02950194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

4.3 years

First QC Date

October 24, 2016

Last Update Submit

July 9, 2020

Conditions

Mesh Augmentation

Keywords

meshrectus diastasispanniculectomyabdominoplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Aesthetic result

    more than 12 months post-operatively

  • Quality of Life score

    more than 12 months post-operatively

Study Arms (1)

PPAWI

patients with multidisciplinary PPAWI approach

Procedure: PPAWI

Interventions

PPAWIPROCEDURE

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

PPAWI

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • No Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Study Officials

  • Filip Muysoms, MD, PhD

    Maria Middelares hospital

    PRINCIPAL INVESTIGATOR

  • Fien Decuypere, MD

    Maria Middelares hospital

    STUDY CHAIR

Central Study Contacts

Filip Muysoms, MD, PhD

CONTACT

003292467416filip.muysoms@azmmsj.be

Iris Kyle-Leinhase, PhD

CONTACT

003292467451iris.kyle-leinhase@azmmsj.be

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
surgeon

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 1, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)