Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT06114758
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-16', 'releaseDate': '2025-09-30'}], 'estimatedResultsFirstSubmitDate': '2025-09-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D014191', 'term': 'Tranylcypromine'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Comparison of patients' preoperative and postoperative hemogram levels", 'timeFrame': '24 hours', 'description': 'The basal hemogram levels ( gr/dL) of the patients will be compared with the hemogram levels at 6 and 24 hours.'}, {'measure': "Comparison of patients' preoperative and postoperative hematocrit levels", 'timeFrame': '24 hours', 'description': 'The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 6 and 24 hours.'}, {'measure': "Comparison of patients' postoperative shock indices", 'timeFrame': '6 hour', 'description': 'postoperative 1st, 2nd, and 6th-hour shock indices (heart rate (beats in minute) / systolic blood pressure(mmHg) ) will be compared'}], 'secondaryOutcomes': [{'measure': "Comparison of the patients' postoperative heart rate", 'timeFrame': '6 hour', 'description': 'Patients postoperative 1st, 2nd, and 6th-hour heart rate (beats in minute) will be compared'}, {'measure': "Comparison of the patients' postoperative systolic and diastolic blood pressure", 'timeFrame': '6 hour', 'description': 'Patients postoperative 1st, 2nd, and 6th-hour systolic and diastolic blood pressure (mmHg) will be compared'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myoma uteri', 'fibroids', 'hemmorhage', 'prostoglandinf2α', 'tranexamic acid'], 'conditions': ['Hemorrhage, Surgical', 'Myoma;Uterus', 'Effect of Drug', 'Postoperative Hemorrhage', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'Fibroids are the most commonly encountered tumors in the female reproductive system. In patients, fibroids most often lead to abnormal uterine bleeding and the resulting anemia. In some cases, they can cause infertility or habitual abortions. Another complaint caused by fibroids is pain due to pressure and effects on adjacent organs. Very large fibroids can lead to abdominal swelling. Therefore, if a patient becomes symptomatic due to fibroids, myomectomy or, if necessary, hysterectomy is required.\n\nBecause fibroids have a significant blood supply, there is a high risk of intraoperative bleeding and related complications. Additionally, the most common complication in these patients after the operation is bleeding. In many of these patients, intraoperative or postoperative blood transfusions are performed. If bleeding cannot be intervened early in these patients, hemodynamic instability, shock, coagulopathy, and, in the final stage, death can occur due to hemorrhage. Therefore, both intraoperative and postoperative bleeding control is of vital importance in patients undergoing myomectomy.', 'detailedDescription': "In this study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (EŞH) between September 1, 2022, and Sempember 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected.\n\nThe parameters to be examined in the research are as follows:\n\n1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).\n2. Shock indices.\n3. Hemogram and hematocrit values at 6-24 hours postoperatively.\n4. Duration of the surgery.\n5. Adverse effects experienced by the patients.\n6. Additional treatments administered.\n7. Whether blood transfusion was performed or not.\n\nIn this study, the G-power analysis program was used to determine the minimum sample size, taking into account a 10% margin of error. According to the analysis results, the minimum number of patients to be included in the study for a total of 75 patients across 3 groups was determined. Statistical analysis of the data obtained in the study will be conducted using the SPSS Statistics 22 software package. A 95% confidence interval will be calculated for each variable, and results will be considered statistically significant for p \\< 0.05."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "In our study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (Etlik City Hospital) between October 1, 2023, and October 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected prospectively", 'genderDescription': 'women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Laparotomic myomectomy surgeries\n* Laparoscopic myomectomy surgeries\n\nExclusion Criteria:\n\n* Identifying missing or suspicious data related to the patient\n* Administering both intraoperative and postoperative medications to the patient'}, 'identificationModule': {'nctId': 'NCT06114758', 'briefTitle': 'Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy', 'orgStudyIdInfo': {'id': 'AEŞH-EK1-2023-383'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group - group 1', 'description': "1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).\n2. Shock indices.\n3. Hemogram and hematocrit values at 6-24 hours postoperatively.\n4. Duration of the surgery.\n5. Adverse effects experienced by the patients.\n6. Additional treatments administered.\n7. Whether blood transfusion was performed or not."}, {'label': 'intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2', 'description': "1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).\n2. Shock indices.\n3. Hemogram and hematocrit values at 6-24 hours postoperatively.\n4. Duration of the surgery.\n5. Adverse effects experienced by the patients.\n6. Additional treatments administered.\n7. Whether blood transfusion was performed or not.", 'interventionNames': ['Drug: Transamine']}, {'label': 'intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2', 'description': "1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).\n2. Shock indices.\n3. Hemogram and hematocrit values at 6-24 hours postoperatively.\n4. Duration of the surgery.\n5. Adverse effects experienced by the patients.\n6. Additional treatments administered.\n7. Whether blood transfusion was performed or not.", 'interventionNames': ['Drug: Cytotec 200Mcg Tablet']}], 'interventions': [{'name': 'Cytotec 200Mcg Tablet', 'type': 'DRUG', 'otherNames': ['misoprostol', 'prostoglandin f2α'], 'description': 'the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered', 'armGroupLabels': ['intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2']}, {'name': 'Transamine', 'type': 'DRUG', 'otherNames': ['tranexamic acid'], 'description': '1 gram intravenous slow infusion intraoperatively as we start the laparatomy', 'armGroupLabels': ['intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical doctor', 'investigatorFullName': 'Tuğba Ağbal', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-30', 'type': 'RELEASE'}, {'date': '2025-10-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tuğba Ağbal, clinical doctor, Ankara Etlik City Hospital'}}}}