Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-20 @ 10:43 PM
Study NCT ID:
NCT01628432
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Salpingectomy During Conservative Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D014596', 'term': 'Uterine Prolapse'}], 'ancestors': [{'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': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2012-06-22', 'studyFirstSubmitQcDate': '2012-06-22', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients with more than 20% diminution of AMH logarithm at one year (12 months)', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'AMH measurement at 3 days, 6 weeks, and 6, 12 months after hysterectomy endovaginal ultrasound evaluation of the ovarian volume and vascularisation quality of life (WHQ questionnaire) reintervention procedures complications', 'timeFrame': 'day3, week 6, month 6 and month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Genital Diseases, Female', 'Hysterotomy; Affecting Fetus', 'Leiomyomata Uteri', 'Adenomyosis, Endometriosis', 'Dysfunctional Uterine Bleeding', 'Cervical Dysplasia', 'Uterine Prolapse']}, 'descriptionModule': {'briefSummary': 'The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.', 'detailedDescription': 'Hysterectomy is one of the most common gynecologic procedures performed in clinical practice. In this study we focused on non menopausal patients under 52 years having hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment.\n\nthe standard procedure during hysterectomy with conservation of the ovaries has been the preservation of fallopian tubes with the clamps placed as close to the uterine corpus as possible. this is suggested to decrease interference with the vascular structures in the mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube, theoretically, these cases could be prevented if tubal excision is performed during hysterectomy The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.\n\nimpact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days, 6 weeks and 6, 12 months after surgeries.\n\nquality of life is also assessed at these time points, with a questionnaire (Women Health Questionnaire WHQ).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age ≥ 18 years and less than 52 years\n* indication of a conservative hysterectomy for benign disease\n* signed informed consent\n* non menopausal women (AMH \\>0,21 ng/ml)\n\nExclusion Criteria:\n\n* pregnancy\n* desire of future pregnancy\n* menopausal status\n* patient unable to give informed consent\n* any physical or psychiatric condition that could impair with patient's ability to cooperate with post operative data collection\n* previous salpingo and /or oophorectomy (unilateral or bilateral)\n* genital cancer disease or atypical endometrial hyperplasia\n* hyperandrogenia\n* any ovarian mass that needs surgical exploration\n* any immunotherapy that could interfere with immunological tests"}, 'identificationModule': {'nctId': 'NCT01628432', 'acronym': 'SALPINGOVA', 'briefTitle': 'Effect of Salpingectomy During Conservative Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PHRN11/LO/SALPINGOVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conservative hysterectomy I', 'description': 'bilateral salpingectomy during hysterectomy with conservation of the ovaries', 'interventionNames': ['Procedure: conservative hysterectomy I']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conservative hysterectomy II', 'description': 'standard conservative hysterectomy with conservation of both ovaries and tubes', 'interventionNames': ['Procedure: Conservative hysterectomy II']}], 'interventions': [{'name': 'conservative hysterectomy I', 'type': 'PROCEDURE', 'description': 'conservative hysterectomy for benign disease', 'armGroupLabels': ['conservative hysterectomy I']}, {'name': 'Conservative hysterectomy II', 'type': 'PROCEDURE', 'description': 'bilateral salpingectomy during hysterectomy without conservation of the ovaries', 'armGroupLabels': ['conservative hysterectomy II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '94 275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59 037', 'city': 'Lille', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69495', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35203', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Lobna OULDAMER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de TOURS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}