Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT02101827
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-04', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2014-03-30', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of manual fluid-distension methods for hysteroscopic procedures', 'timeFrame': '1 week', 'description': 'The complications (such as hyponatremia, abdominal pain) related to manual fluid-distension methods for hysteroscopic procedures.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of manual fluid-infusion methods for hysteroscopic procedures', 'timeFrame': '1 week', 'description': 'The perioperative data, including operation time, estimated blood loss, completion operation rate of hysteroscopic procedure by using manual fluid-infusion methods'}]}, 'conditionsModule': {'conditions': ['Hysteroscopic Surgery']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.', 'detailedDescription': 'In order to minimize the amount of distending media infused during hysteroscopic procedures, investigators used manual syringe method for delivering of distending media during hysteroscopic procedures from June 2010 to November 2013 in our institute. The aim of this study was to evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.\n\nThe medical records of all women who received hysteroscopic procedures by manual fluid-infusion method or convention pump fluid infusion method between June 2010 and November 2013 will be reviewed. In order to reveal the superiority/inferiority of clinical outcome of women receiving manual fluid infusion method, perioperative outcomes will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.\n* Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose from June 2010 to November 2013 in Department of Obstetrics \\& Gynecology in Far Eastern Memorial Hospital.\n\nExclusion Criteria:\n\n* Female patients of less than twenty years-old.'}, 'identificationModule': {'nctId': 'NCT02101827', 'briefTitle': 'Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures', 'orgStudyIdInfo': {'id': '103006-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hysteroscopic surgery', 'description': 'Women who received hysteroscopic surgeries or examinations'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Banqiao District', 'state': 'New Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Obstetrics & Gynecology', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}