Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-18 @ 2:52 PM
Study NCT ID:
NCT00672750
Status:
TERMINATED
Last Update Posted:
2017-01-26
First Post:
2008-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'did not have resources to continue this study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2008-05-01', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases', 'timeFrame': 'since 1999'}], 'secondaryOutcomes': [{'measure': 'That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time', 'timeFrame': 'since 1999'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'myomectomy', 'menorrhagia', 'pelvic pain'], 'conditions': ['Laparoscopic Myomectomy']}, 'descriptionModule': {'briefSummary': 'This will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. The data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.', 'detailedDescription': 'Patients will be called and surveyed using a survey tool. They will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are willing to be surveyed\n\nExclusion Criteria:\n\n* Those patients who are not willing to answer the survey will be excluded\n\n * Those patients who are unable to be contacted( ie; moved) will be excluded'}, 'identificationModule': {'nctId': 'NCT00672750', 'acronym': 'retromyo', 'briefTitle': 'A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Advanced Gynecologic Surgery Institute'}, 'officialTitle': 'A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy', 'orgStudyIdInfo': {'id': '23597'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'I', 'description': 'Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advanced Gynecologic Surgery Institute', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}], 'overallOfficials': [{'name': 'Charles E Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced gynecologic surgery institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Advanced Gynecologic Surgery Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Charles E Miller MD', 'investigatorAffiliation': 'The Advanced Gynecologic Surgery Institute'}}}}