Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT01586559
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2012-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-26', 'studyFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2012-04-26', 'lastUpdatePostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the long-term stability of sheath plication using absorbable sutures in patients with diastasis of the recti muscles', 'timeFrame': '12-41 months'}]}, 'conditionsModule': {'conditions': ['Diastasis Recti']}, 'descriptionModule': {'briefSummary': 'A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.', 'detailedDescription': 'Background: Rectus sheath plication within abdominoplasty is a standard treatment for diastasis of the recti muscles. Previous studies assessing the efficacy and endurance of the correction of recti diastasis have mostly been performed with small groups of patients, short follow-up periods and/or with questionable methodology\n\nMethods: A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture. The investigators assess the outcomes by physical and ultrasonographic examinations and a patient questionnaire, which asks about the number of pregnancies and the types of deliveries, other abdominal surgeries before or after the abdominoplasty, the interval of time required to return to full activity, postoperative pain, and the overall satisfaction with the final result. During the examination, the inter-recti distances are measured at 3 levels: halfway between the xyphoid and umbilicus, just above the umbilicus and halfway between the umbilicus and pubis. The same examination is done on a control group of nulliparous women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with interval after rectus sheath plication', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen after rectus sheath plication for diastasis recti\n\nExclusion Criteria:\n\nAbdominal wall defect other then umbilical hernia'}, 'identificationModule': {'nctId': 'NCT01586559', 'briefTitle': 'Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study', 'organization': {'class': 'OTHER', 'fullName': 'Bulovka Hospital'}, 'officialTitle': 'Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study', 'orgStudyIdInfo': {'id': 'IGANT11 392-6/2010-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Nulliparous women'}, {'label': 'Diastasis', 'description': 'Patients after rectus sheath plication due to diastasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Bulovka Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulovka Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ondrej Mestak M.D.', 'investigatorFullName': 'Ondrej Mestak M.D.', 'investigatorAffiliation': 'Bulovka Hospital'}}}}