Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT03171467
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2017-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-28', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy', 'timeFrame': 'At time of laparoscopic cholecystectomy surgery', 'description': 'Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy'}], 'secondaryOutcomes': [{'measure': 'Time', 'timeFrame': 'At the time of surgery', 'description': 'Time (in minutes) from completion of cholecystectomy to completion of bilateral salpingectomy'}, {'measure': 'Port repositioning', 'timeFrame': 'At surgery', 'description': 'Rate of port repositioning'}, {'measure': 'Complications', 'timeFrame': '30 days', 'description': 'Number of complications due to salpingectomy'}, {'measure': 'Patient-recorded outcome', 'timeFrame': 'Preop. and 1 year', 'description': 'Bliem Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prophylactic Salpingectomy', 'Opportunistic Salpingectomy', 'Laparoscopic Cholecystectomy']}, 'referencesModule': {'references': [{'pmid': '28334425', 'type': 'BACKGROUND', 'citation': 'Long Roche KC, Abu-Rustum NR, Nourmoussavi M, Zivanovic O. Risk-reducing salpingectomy: Let us be opportunistic. Cancer. 2017 May 15;123(10):1714-1720. doi: 10.1002/cncr.30528. Epub 2017 Mar 23.'}, {'pmid': '25560145', 'type': 'BACKGROUND', 'citation': 'Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09.'}, {'pmid': '25628372', 'type': 'BACKGROUND', 'citation': 'Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.'}, {'pmid': '27012190', 'type': 'BACKGROUND', 'citation': 'Kurman RJ, Shih IeM. The Dualistic Model of Ovarian Carcinogenesis: Revisited, Revised, and Expanded. Am J Pathol. 2016 Apr;186(4):733-47. doi: 10.1016/j.ajpath.2015.11.011.'}]}, 'descriptionModule': {'briefSummary': 'Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).', 'detailedDescription': 'Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.\n\nThis study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled (elective) laparoscopic cholecystectomy for a benign indication\n* Age \\>45 years\n* Consent\n\nExclusion Criteria:\n\n* Age \\<45 years\n* Desire to preserve fertility\n* Cholecystectomy for malignant disease\n* Extensive previous abdominal surgery'}, 'identificationModule': {'nctId': 'NCT03171467', 'acronym': 'SaLCHE', 'briefTitle': 'Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study', 'orgStudyIdInfo': {'id': 'SaLCHE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salpingectomy', 'description': 'Opportunistic salpingectomy at the time of laparoscopic cholecystectomy', 'interventionNames': ['Procedure: Salpingectomy']}], 'interventions': [{'name': 'Salpingectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Salpingectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8330', 'city': 'Feldbach', 'country': 'Austria', 'facility': 'Landeskrankenhaus Feldbach', 'geoPoint': {'lat': 46.95306, 'lon': 15.88833}}, {'zip': '8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'Krankenhaus der Barmherzigen Brüder Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'Krankenhaus der Elisabethinen Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8230', 'city': 'Hartberg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Hartberg', 'geoPoint': {'lat': 47.28333, 'lon': 15.96667}}, {'zip': '9300', 'city': 'Saint Veit/Glan', 'country': 'Austria', 'facility': 'Krankenhaus der Barmherzigen Brüder St. Veit/Glan'}], 'overallOfficials': [{'name': 'Karl F Tamussino, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Krankenhaus der Barmherzigen Brüder Graz', 'class': 'UNKNOWN'}, {'name': 'Krankenhaus der Elisabethinen Graz', 'class': 'UNKNOWN'}, {'name': 'Landeskrankenhaus Feldbach', 'class': 'OTHER'}, {'name': 'LKH Hartberg', 'class': 'UNKNOWN'}, {'name': 'Krankenhaus der Barmherzigen Brüder St. Veit/Glan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}