Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT03986450
Status:
UNKNOWN
Last Update Posted:
2019-06-14
First Post:
2019-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ERAS Protocol in Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare costs', 'timeFrame': 'Up to one month', 'description': 'Hospital costs will be obtained from the accounting office of the hospital'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Up to one month', 'description': 'Length of hospital stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enhanced recovery after surgery', 'Laparoscopic hysterectomy'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy.', 'detailedDescription': 'ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay in various kinds of surgical procedures. This study aimed to investigate whether ERAS protocol has an impact on healthcare costs in patients undergoing a laparoscopic hysterectomy. Patients scheduled for laparoscopic hysterectomy will be allocated to one of the study groups: ERAS group patients will receive ERAS protocol during the perioperative period; Conventional care groups will undergo standard abdominal hysterectomy without the implementation of ERAS protocol. The groups will be compared with respect to the length of hospital stay, rehospitalizations, and healthcare costs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be scheduled for laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) class IV\n* Development of complications during surgery\n* Body mass index \\> 40 kg/m2'}, 'identificationModule': {'nctId': 'NCT03986450', 'briefTitle': 'ERAS Protocol in Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Impact of Implementing ERAS Protocol on Healthcare Costs in Patients Undergoing Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': 'AYSUAKCA2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ERAS group', 'description': 'Patients in this group will receive ERAS protocol preoperatively, perioperatively and postoperatively.', 'interventionNames': ['Other: Enhanced recovery after surge(ERAS) protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group of patients will not receive ERAS care and will undergo a standard laparoscopic hysterectomy.'}], 'interventions': [{'name': 'Enhanced recovery after surge(ERAS) protocol', 'type': 'OTHER', 'description': 'The components of ERAS multidisciplinary pathway concerning preoperative, operative, and postoperative period are as follows:\n\n1. Preoperative care:\n\n Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis\n2. Perioperative care:\n\nUse of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia\n\nPostoperative care:\n\nApplication of midthoracic, epidural anesthesia/analgesia Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization', 'armGroupLabels': ['ERAS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34005', 'city': 'Istanbul', 'state': 'Please Enter the State Or Province', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Aysu Akca, MD', 'role': 'CONTACT', 'email': 'aysuakca4@gmail.com', 'phone': '+902124041500'}], 'overallOfficials': [{'name': 'Aysu Akca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Suleyman Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, M.D.', 'investigatorFullName': 'Aysu Akca', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}