Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-06 @ 11:18 AM
Study NCT ID:
NCT02581293
Status:
UNKNOWN
Last Update Posted:
2015-10-20
First Post:
2015-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative vital sign (arterial tension)', 'timeFrame': 'First postoperative hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.', 'detailedDescription': 'At c-section subject will be randomised into four groups:\n\nGroup1: Only visceral peritoneum will be closed\n\nGroup 2: Only parietal peritoneum will be closed\n\nGroup 3: Both of them will be closed\n\nGroup 4: None of them will be closed\n\nDuring the postoperative period all patients will undergo vital sign screening including urine output, blood pressure measurement, pulse rate and VAS score will be determined at post operative 6th hour and 24th hour.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women underwent uncomplicated c-section\n\nExclusion Criteria:\n\n* Patient with systemic Diseases\n* Pregnant with Obstetric complications\n* Pregnant with two or more previous c-sections'}, 'identificationModule': {'nctId': 'NCT02581293', 'briefTitle': 'Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs', 'organization': {'class': 'OTHER', 'fullName': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}, 'officialTitle': 'Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs', 'orgStudyIdInfo': {'id': '31/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Only visceral peritoneum will be closed', 'description': 'Group1: Only visceral peritoneum will be closed', 'interventionNames': ['Procedure: Group 1: Only visceral peritoneum will be closed']}, {'type': 'EXPERIMENTAL', 'label': 'Only parietal peritoneum will be closed', 'description': 'Group 2: Only parietal peritoneum will be closed', 'interventionNames': ['Procedure: Group 2 : Only parietal peritoneum will be closed']}, {'type': 'EXPERIMENTAL', 'label': 'Both of them will be closed', 'description': 'Group 3: Both of them will be closed', 'interventionNames': ['Procedure: Group 3 : Both of them will be closed']}, {'type': 'EXPERIMENTAL', 'label': 'None of them will be closed', 'description': 'Group 4: None of them will be closed', 'interventionNames': ['Procedure: Group 4: None of them will be closed']}], 'interventions': [{'name': 'Group 1: Only visceral peritoneum will be closed', 'type': 'PROCEDURE', 'armGroupLabels': ['Only visceral peritoneum will be closed']}, {'name': 'Group 2 : Only parietal peritoneum will be closed', 'type': 'PROCEDURE', 'armGroupLabels': ['Only parietal peritoneum will be closed']}, {'name': 'Group 3 : Both of them will be closed', 'type': 'PROCEDURE', 'armGroupLabels': ['Both of them will be closed']}, {'name': 'Group 4: None of them will be closed', 'type': 'PROCEDURE', 'armGroupLabels': ['None of them will be closed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34280', 'city': 'Istanbul', 'state': 'Üsküdar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Meryem Kurek EKEN, MD', 'role': 'CONTACT', 'email': 'meryemkurek@yahoo.com', 'phone': '+905305104468'}], 'facility': 'Meryem Kurek EKEN', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Meryem Kurek EKEN, MD', 'role': 'CONTACT', 'email': 'meryemkurek@yahoo.com', 'phone': '+905305104468'}], 'overallOfficials': [{'name': 'Enis Özkaya, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'MERYEM Kurek EKEN', 'investigatorAffiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}}}}