Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 2:36 PM
Study NCT ID:
NCT04296760
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina', 'timeFrame': 'At maximum 6 months before undergoing laparoscopic surgical approach'}], 'secondaryOutcomes': [{'measure': 'Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis', 'timeFrame': 'At maximum 6 months before undergoing laparoscopic surgical approach'}, {'measure': 'Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge', 'timeFrame': 'At maximum 6 months before undergoing laparoscopic surgical approach'}, {'measure': 'Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis', 'timeFrame': 'At maximum 6 months before undergoing laparoscopic surgical approach'}, {'measure': 'Accuracy in estimating the largest diameter of endometriosis nodules in the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina', 'timeFrame': 'At maximum 6 months before undergoing laparoscopic surgical approach'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis'], 'conditions': ['Endometriosis, Rectum', 'Endometriosis of Vagina', 'Endometriosis Rectovaginal Septum', 'Endometriosis Pelvic', 'Endometriosis of Colon', 'Endometriosis']}, 'referencesModule': {'references': [{'pmid': '27060846', 'type': 'BACKGROUND', 'citation': 'Leone Roberti Maggiore U, Biscaldi E, Vellone VG, Venturini PL, Ferrero S. Magnetic resonance enema vs rectal water-contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis. Ultrasound Obstet Gynecol. 2017 Apr;49(4):524-532. doi: 10.1002/uog.15934.'}, {'pmid': '26935873', 'type': 'BACKGROUND', 'citation': 'Ferrero S, Biscaldi E, Vellone VG, Venturini PL, Leone Roberti Maggiore U. Computed tomographic colonography vs rectal water- contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis: a pilot study. Ultrasound Obstet Gynecol. 2017 Apr;49(4):515-523. doi: 10.1002/uog.15905.'}]}, 'descriptionModule': {'briefSummary': 'As the surgical treatment of posterior deep endometriosis may be challenging for surgeons and carry significant risks for patients, preoperative assessment of the location, characteristics and presence of nodules of posterior deep endometriosis is important in order to inform the patient about the various treatment possibilities and to allow adequate counseling regarding treatment strategy. The aim of this study is to investigate the accuracy of rectal water-contrast transvaginal ultrasonography (RWC-TVS), and sonovaginography (SVG) in patients with clinical suspicion of posterior deep endometriosis (DIE).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspicion of posterior deep infiltrating endometriosis, referring to our academic department for diagnostic purposes', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis\n\nExclusion Criteria:\n\n* previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)\n* previous surgical diagnosis of posterior deep infiltrating endometriosis'}, 'identificationModule': {'nctId': 'NCT04296760', 'briefTitle': 'Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Policlinico San Martino'}, 'officialTitle': 'Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis', 'orgStudyIdInfo': {'id': 'ENHANCED-ETV-ENDO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with suspicious of deep posterior pelvic endometriosis', 'interventionNames': ['Diagnostic Test: Rectal water-contrast transvaginal ultrasonography', 'Diagnostic Test: Sonovaginography']}], 'interventions': [{'name': 'Rectal water-contrast transvaginal ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum', 'armGroupLabels': ['Women with suspicious of deep posterior pelvic endometriosis']}, {'name': 'Sonovaginography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina', 'armGroupLabels': ['Women with suspicious of deep posterior pelvic endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1632', 'city': 'Genoa', 'country': 'Italy', 'facility': 'Ospedale Policlinico San Martino', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}], 'overallOfficials': [{'name': 'Fabio Barra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Policlinico San Martino'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fabio Barra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fabio Barra', 'investigatorAffiliation': 'Ospedale Policlinico San Martino'}}}}