Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-04-03 @ 3:12 PM
Study NCT ID:
NCT04411004
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persistence Disease After Laparoscopic Shaving of Rectal 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with rectal recurrence of endometriosis', 'timeFrame': '3 months after the surgical approach', 'description': 'Evaluated by ultrasound'}, {'measure': 'Number of patients with rectal recurrence of endometriosis', 'timeFrame': '6 months after the surgical approach', 'description': 'Evaluated by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Satisfaction of patients to the previous surgical treatment', 'timeFrame': '3 months after the surgical approach', 'description': 'Evaluated by five-point Likert scale'}, {'measure': 'Volume of nodules in patients with rectal recurrence of endometriosis', 'timeFrame': '3 months after the surgical approach', 'description': 'Evaluated by ultrasound'}, {'measure': 'Satisfaction of patients to the previous surgical treatment', 'timeFrame': '6 months after the surgical approach', 'description': 'Evaluated by five-point Likert scale'}, {'measure': 'Volume of nodules in patients with rectal recurrence of endometriosis', 'timeFrame': '6 months after the surgical approach', 'description': 'Evaluated by ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis, Rectum']}, 'referencesModule': {'references': [{'pmid': '31919838', 'type': 'BACKGROUND', 'citation': 'Alhayo S, Leonardi M, Lu C, Gosal P, Reid S, Barto W, Condous G. Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study. Aust N Z J Obstet Gynaecol. 2020 Apr;60(2):258-263. doi: 10.1111/ajo.13112. Epub 2020 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Theoretically, compared with segmental bowel resection, the shaving technique may expose the patients to a higher risk of persistence of intestinal endometriosis. The objective of this ultrasonographic study was to assess the risk of rectal endometriosis persistence following laparoscopic shaving of rectovaginal nodules.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent shaving of rectal endometriosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum\n\nExclusion Criteria:\n\n* patients underwent previous bowel surgery (except appendectomy);\n* patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)'}, 'identificationModule': {'nctId': 'NCT04411004', 'acronym': 'ENDO-SHAVING', 'briefTitle': 'Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Policlinico San Martino'}, 'officialTitle': 'Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum', 'orgStudyIdInfo': {'id': 'ENDO-SHAVING'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women who underwent shaving for rectal endometriosis', 'interventionNames': ['Diagnostic Test: Transvaginal ultrasound', 'Behavioral: 5-point Likert scale']}], 'interventions': [{'name': 'Transvaginal ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis', 'armGroupLabels': ['Women who underwent shaving for rectal endometriosis']}, {'name': '5-point Likert scale', 'type': 'BEHAVIORAL', 'description': 'Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis', 'armGroupLabels': ['Women who underwent shaving for rectal endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genoa', 'country': 'Italy', 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fabio Barra', 'investigatorAffiliation': 'Ospedale Policlinico San Martino'}}}}