Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02674035
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2015-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061645', 'term': 'Abdominoplasty'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2015-11-08', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correction of diastasis of the rectus abdominis muscles', 'timeFrame': 'Compare from the baseline the efficacy and time required to correct the diastasis at 3 weeks', 'description': 'Get a technique that provides a safe abdominoplasty correction with lasting results and in every segment of time.'}], 'secondaryOutcomes': [{'measure': 'Follow-up of diastasis of the rectus abdominis muscles', 'timeFrame': 'At six months', 'description': 'Confirms the plication of a single layer abdominoplasty as positive in women patients at six months of surgery compared to two planes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominoplasty', 'Sutures', 'Abdominal deformities', 'Plication', 'Monofilament nylon suture', 'Barbed suture'], 'conditions': ['Disorder of Abdomen']}, 'descriptionModule': {'briefSummary': 'Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.', 'detailedDescription': 'Inclusion criteria were female gender; 25 to 50 years of age; history of at least one pregnancy; body mass index (BMI) between 18 and 30 kg/m2; desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries; deformities of the skin and subcutaneous tissues in the abdominal region; and musculoaponeurotic defect.\n\nNon-inclusion criteria were smoking habit; abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section); abdominal wall hérnias; history of deep-vein thrombosis; chronic obstructive pulmonary disease; câncer; hypertension; diabetes or other chronic systemic diseases; and use of corticosteroids. Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study.\n\nPrimary outcome: Get a technique that provides a safe correction with lasting results and in every segment of time.\n\nSecondary clinical outcome: confirms the plication of a single layer as positive in women patients at two years of surgery compared to two planes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female gender\n* Age: 25 to 50 years of age\n* History of at least one pregnancy\n* Body mass index (BMI) between 18 and 30 kg/m2\n* Desire to undergo abdominoplasty as a single procedure without receiving liposuction or other cosmetic surgeries\n* Deformities of the skin and subcutaneous tissues in the abdominal region\n* Musculoaponeurotic defect\n\nExclusion Criteria:\n\n* Smoking habit;\n* Abdominal wall scar (except for a Pfannenstiel scar related to a Cesarean section);\n* Abdominal wall hérnias;\n* History of deep-vein thrombosis;\n* Chronic obstructive pulmonary disease;\n* Câncer;\n* Hypertension;\n* Diabetes or other chronic systemic diseases;\n* Use of corticosteroids.\n* Patients lost to follow-up and those who did not undergo ultrasound examination were excluded from the study'}, 'identificationModule': {'nctId': 'NCT02674035', 'briefTitle': 'Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Plication of the Rectus Abdominis in Two Planes and in One Continuous Suture Plan', 'orgStudyIdInfo': {'id': 'U1111-1175-1484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Device: 2-0 monofilament nylon suture', 'description': 'Plication of the anterior rectus sheath (correction of diastasis of the rectus abdominis muscles) was performed in two layers with Device 2-0 monofilament nylon suture (control group). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.', 'interventionNames': ['Procedure: Correction of diastasis of the rectus abdominis muscles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Device: Single layer 2-0 monofilament', 'description': 'Single layer with a Device 2-0 monofilament nylon suture (correction of diastasis of the rectus abdominis muscles) (group I). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.', 'interventionNames': ['Procedure: Correction of diastasis of the rectus abdominis muscles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Device: Barbed suture Quill Nylon 1', 'description': 'Using a continuous Device Barbed suture Quill Nylon 1 (correction of diastasis of the rectus abdominis muscles) (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.', 'interventionNames': ['Procedure: Correction of diastasis of the rectus abdominis muscles']}], 'interventions': [{'name': 'Correction of diastasis of the rectus abdominis muscles', 'type': 'PROCEDURE', 'otherNames': ['Abdominoplasty'], 'description': 'Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.', 'armGroupLabels': ['Device: 2-0 monofilament nylon suture', 'Device: Barbed suture Quill Nylon 1', 'Device: Single layer 2-0 monofilament']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fábio Xerfan Nahas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luiz José Muaccad Gama, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de São Paulo - UNIFESP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luiz Jose Muaccad Gama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Luiz Jose Muaccad Gama', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}