Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT01578759
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2012-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058994', 'term': 'Salpingectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-04-15', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)', 'timeFrame': 'AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.'}], 'secondaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'Prior to surgery', 'description': 'The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication.'}, {'measure': 'Patient surgical outcomes', 'timeFrame': 'Postoperatively on day 1', 'description': 'The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ovarian function tests'], 'conditions': ['Laparoscopic Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '23993887', 'type': 'DERIVED', 'citation': 'Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.\n\nExclusion Criteria:\n\n* Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).\n* Personal history of gynecologic cancer\n* Pregnancy\n* Non-English speaking\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01578759', 'briefTitle': 'Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function', 'orgStudyIdInfo': {'id': '12-0440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salpingectomy group', 'description': 'Participants in this group will have their fallopian tubes removed.', 'interventionNames': ['Procedure: Salpingectomy']}, {'type': 'NO_INTERVENTION', 'label': 'No Salpingectomy Group', 'description': 'Participants in this group will not have their fallopian tubes removed.'}], 'interventions': [{'name': 'Salpingectomy', 'type': 'PROCEDURE', 'description': 'Removal of the fallopian tubes', 'armGroupLabels': ['Salpingectomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Austin Findley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}