Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02950194
Status:
UNKNOWN
Last Update Posted:
2020-07-10
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the rectus diastasis by ultrasound', 'timeFrame': 'more than 12 months post-operatively', 'description': 'Evaluation of the rectus diastasis after abdominoplasty with mesh augmentation using ultrasound at least 12 months post-operatively'}], 'secondaryOutcomes': [{'measure': 'Aesthetic result', 'timeFrame': 'more than 12 months post-operatively', 'description': 'Aesthetic result evaluated by physical examination'}, {'measure': 'Quality of Life score', 'timeFrame': 'more than 12 months post-operatively', 'description': 'Quality of Life score assessment with the EuraHS QoL score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mesh', 'rectus diastasis', 'panniculectomy', 'abdominoplasty'], 'conditions': ['Mesh Augmentation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTo 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.\n\nAn 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.\n\nSince 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.\n\nThe 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.\n\nThe aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI at least one year post-operatively by clinical and radiological examination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '11 patients were already operated by Dr. Filip Muysoms and Dr. Rudolf Vertriest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients who underwent an abdominal wall repair and an abdominoplasty in one-step technique\n\nExclusion Criteria:\n\n* Pregnancy\n* No Informed Consent'}, 'identificationModule': {'nctId': 'NCT02950194', 'acronym': 'PPAWI', 'briefTitle': 'Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Algemeen Ziekenhuis Maria Middelares'}, 'officialTitle': 'Navel Sparing Retro-muscular Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency (PPAWI)', 'orgStudyIdInfo': {'id': 'PPAWI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPAWI', 'description': 'patients with multidisciplinary PPAWI approach', 'interventionNames': ['Procedure: PPAWI']}], 'interventions': [{'name': 'PPAWI', 'type': 'PROCEDURE', 'description': 'One-step procedure of a panniculectomy performed by a plastic surgeon together with a mesh augmentation of the abdominal wall by a general surgeon.', 'armGroupLabels': ['PPAWI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Iris Kyle-Leinhase, PhD', 'role': 'CONTACT', 'email': 'iris.kyle-leinhase@azmmsj.be', 'phone': '003292467451'}, {'name': 'Filip Muysoms, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Filip Muysoms, MD, PhD', 'role': 'CONTACT', 'email': 'filip.muysoms@azmmsj.be', 'phone': '003292467416'}, {'name': 'Iris Kyle-Leinhase, PhD', 'role': 'CONTACT', 'email': 'iris.kyle-leinhase@azmmsj.be', 'phone': '003292467451'}], 'overallOfficials': [{'name': 'Filip Muysoms, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Middelares hospital'}, {'name': 'Fien Decuypere, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maria Middelares hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Algemeen Ziekenhuis Maria Middelares', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'surgeon', 'investigatorFullName': 'Filip Muysoms', 'investigatorAffiliation': 'Algemeen Ziekenhuis Maria Middelares'}}}}