Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 3:23 PM
Study NCT ID:
NCT07064850
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-06
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Vasomotor Symptom Frequency', 'timeFrame': 'Baseline period to 2 weeks pre-operative', 'description': 'One primary outcome measure is the change in average vasomotor symptom frequency score from baseline (pre-operative) to 2 weeks post-operative. The symptoms evaluated will be hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how often they experience each symptom: never, rarely, sometimes, or often. For each symptom, average scores at baseline will be compared to scores collected 2 weeks after surgery to assess changes in symptom frequency.'}, {'measure': 'Changes in Vasomotor Symptom Distress', 'timeFrame': 'Baseline period to 2 weeks pre-operative', 'description': 'One primary outcome measure is the change in average vasomotor symptom distress scores from baseline (pre-operative) to 2 weeks post-operative. The symptoms assessed will include hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how bothersome each symptom is using a 7-point Likert scale (0 = not at all bothersome, 6 = extremely bothersome). For each symptom, average distress scores at baseline will be compared to those collected 2 weeks post-operatively to evaluate changes in perceived symptom burden. Higher scores indicate greater symptom distress.'}], 'secondaryOutcomes': [{'measure': 'Thematic Analysis of Patient-Reported Symptom Experiences', 'timeFrame': 'Baseline period to 2 weeks post-operative', 'description': 'This secondary outcome measure involves the qualitative analysis of patient comments related to symptom experiences. Participants will have the option to provide open-ended feedback in both the pre-operative and post-operative surveys. The qualitative data will focus on the same vasomotor symptoms assessed quantitatively (hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations), as well as any additional symptoms reported after surgery. Patient narratives will be analyzed using thematic analysis to identify recurring themes and the overall impact of symptoms on daily life. This qualitative component is intended to provide contextual depth to the quantitative symptom distress scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysterectomy'], 'conditions': ['Vasomotor Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about vasomotor symptoms (such as hot flashes and night sweats) in the short-term period after a hysterectomy.\n\nThe main question it aims to answer is: How common and severe are vasomotor symptoms shortly after surgery in people who have had a hysterectomy?\n\nParticipants will complete a survey before surgery to assess baseline symptoms, and again 2 weeks after surgery to see if there are any changes.', 'detailedDescription': 'Hysterectomies are among the most common surgical procedures for women in the United States, with approximately 600,000 operations performed annually. Traditionally, it has been assumed that retaining one or both ovaries during hysterectomy mitigates the onset and severity of vasomotor symptoms, such as hot flashes and night sweats. However, recent research indicates that even with ovarian conservation, women may experience a higher incidence of persistent vasomotor symptoms compared to those who have not had the surgery. These symptoms can significantly impact quality of life, underscoring the need for comprehensive studies that track the progression of vasomotor symptoms post-hysterectomy. Despite their clinical importance, the precise timeline of symptom onset and the influence of ovarian retention remain poorly understood.\n\nExisting studies on surgical menopause primarily focus on factors such as depression, anxiety, and abdominal pain. No study to date has followed women from the immediate postoperative period through the subsequent months to assess the onset, type, and frequency of vasomotor symptoms. Additionally, research on surgical menopause often lacks detailed information on the diagnostic indications for hysterectomy and fails to differentiate between women who retained both ovaries versus those who retained only one at the time of surgery. This study aims to provide a better understanding of the relationship between the onset and severity of vasomotor symptoms in order to improve postoperative care, guide patient counseling, and develop targeted interventions to mitigate vasomotor symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients scheduled for hysterectomy with ovarian conservation at an urban academic medical center. Participants will be recruited from the surgical gynecology service.', 'genderDescription': 'cisgender women', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 35-50 years old\n2. Undergoing hysterectomy with at least one ovary conserved\n3. Ability to provide informed consent\n\nExclusion Criteria:\n\n(None specified)'}, 'identificationModule': {'nctId': 'NCT07064850', 'briefTitle': 'Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation: A Prospective Study', 'orgStudyIdInfo': {'id': 'STU00223626'}}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Magdy P Milad, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Magdy Milad, MD', 'investigatorAffiliation': 'Northwestern University'}}}}