Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-10 @ 7:42 PM
Study NCT ID:
NCT03080558
Status:
UNKNOWN
Last Update Posted:
2019-02-04
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Per-operative evaluation of the rectum', 'timeFrame': 'at day 1', 'description': 'Per-operative evaluation of the rectum after Shaving, using indocyanine green fluorescence, by transperitoneal and intra-rectal approach, and vaginal suture if there is an associated vaginal resection. A fluorescence score between 0 and 4 will be used, based on a Likert scale'}], 'secondaryOutcomes': [{'measure': 'Side effects after indocyanine green injection', 'timeFrame': 'at day 1'}, {'measure': 'Post operative complications', 'timeFrame': 'at day 1', 'description': 'infections, abdominal abscess, abdominal hematoma, post operative fistula.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indocyanine green fluorescence', 'Rectal vascularisation', 'Vaginal vascularisation', 'Laparoscopic surgery', 'Rectal shaving', 'Recto vaginal node', 'Deep Endometriosis'], 'conditions': ['Deep Endometriosis', 'Recto Vaginal Node']}, 'referencesModule': {'references': [{'pmid': '32646588', 'type': 'DERIVED', 'citation': 'Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.'}, {'pmid': '29885885', 'type': 'DERIVED', 'citation': 'Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion.\n\nAfter intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent.\n\nIn endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula.\n\nAn abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas.\n\nThe aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.', 'detailedDescription': 'Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH \\& Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located.\n\nIf a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.\n\nTo estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.\n\nAfter the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above the age of 18 year\n* Patients with endometriosis recto vaginal node\n* Patients with operative indications of rectal shaving, with or without vaginal resection\n* Patients who have accepted to participate\n\nExclusion Criteria:\n\n* minors patients\n* Patients under guardianship or wardship\n* Patients who refused the participation\n* Iodine allergy\n* Pregnant woman\n* Patients during lactation'}, 'identificationModule': {'nctId': 'NCT03080558', 'acronym': 'INDIE', 'briefTitle': 'Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study', 'orgStudyIdInfo': {'id': 'CHU-305'}, 'secondaryIdInfos': [{'id': '2016-002773-35', 'type': 'OTHER', 'domain': '2016-002773-35'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'endometriosis recto vaginal node', 'interventionNames': ['Drug: Indocyanine green']}], 'interventions': [{'name': 'Indocyanine green', 'type': 'DRUG', 'description': 'Use of Indocyanine Green during Rectal shaving by laparoscopy.', 'armGroupLabels': ['endometriosis recto vaginal node']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Nicolas BOURDEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '0473751195'}], 'overallOfficials': [{'name': 'Nicolas BOURDEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratoire SERB', 'class': 'UNKNOWN'}, {'name': 'Association GEGO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}