Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT03555903
Status:
RECRUITING
Last Update Posted:
2021-07-27
First Post:
2018-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of the management of deep endometriosis on the quality of life', 'timeFrame': '5 years', 'description': 'Evolution of SF 36 quality of life scores.'}, {'measure': 'The impact of the management of deep endometriosis on the quality of life', 'timeFrame': '5 years', 'description': 'Evolution of EHP-30 quality of life scores.'}], 'secondaryOutcomes': [{'measure': 'Describe endometriosis', 'timeFrame': '5 years', 'description': 'Description of the study population : Socio-demographic data'}, {'measure': 'Describe risk factors of the disease.', 'timeFrame': '5 years', 'description': 'Postoperative complications (DINDO classification)'}, {'measure': 'Describe diagnostic delay of the disease.', 'timeFrame': '5 years', 'description': 'Description of diagnostic.'}, {'measure': 'Describe diagnostic management of the disease.', 'timeFrame': '5 years', 'description': 'Description of therapeutic management : Diagnostic loadings'}, {'measure': 'Impact of the management of deep endometriosis on the use of assisted reproductive therapy.', 'timeFrame': '5 years', 'description': 'Impact on fertility.'}, {'measure': 'Describe risk factors of the disease.', 'timeFrame': '5 years', 'description': 'Recurrence of endometriosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Infiltrating Endometriosis']}, 'descriptionModule': {'briefSummary': 'Endometriosis is a common gynaecologic disease affecting 5 to 15% women of reproductive age and up to 40% of infertile women. It is characterized by the presence of active endometrial tissue outside the uterine cavity, potentially causing invalidating chronic pelvic pain and infertility. It is therefore crucial to limit the progression and/or recurrence of the disease, and to improve the quality of life of affected women.\n\nDeep infiltrating endometriosis (DIE), an advanced form of the disease, is defined by the invasion of an anatomical structure and organ close to the uterus (i.e. uterosacral ligament, rectovaginal space, recto-sigmoidal colon or bladder), or by a peritoneal invasion greater than 5mm. The management of DIE is unfortunately not yet based on high-level evidence data; it mainly depends on the localization of the disease, the extend of the invasion and the severity of the symptoms. In the absence of clear guidelines based on empirical data, the choice between surgical or medical treatment remains difficult and controversial.\n\nTo improve optimal DIE management, the investigators aim to create a prospective database reporting on DIE surgically treated in a teaching hospital in Lyon/France (Centre hospitalier universitaire Lyon Sud)\n\nData on known risks factors, symptoms (pain), quality of life, infertility history and disease management will be obtained using self-questionnaires, clinic, paraclinic, surgical and histological records as follow.\n\n1. Each patient will be asked to fill in electronics protected on-line forms: the first one before surgery, followed by three follow-up forms at 1, 2 and 5 years after surgery.\n2. The surgeon will be asked to fill in two electronic protected on-line forms: the first one at the time of surgery and the second one during a post-operative consultation (one month after surgery).\n\nThe questionnaires used in this study are similar to those used for the Endometriosis database "CIRENDO" (explain briefly what it is), which will ultimately allow us to pool the data from the 2 databases.\n\nThis French prospective study will advance the scientific knowledge on DIE surgical treatment and, by helping evaluate the impact of the surgery on the quality of life and fertility of affected women, will guide future recommendations for an optimal management of this invalidating disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients surgically managed for deep endometriosis in Centre hospitalier Lyon sud, Lyon, France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgically management for deep endometriosis\n\nExclusion Criteria:\n\n* No surgical management necessary\n* Isolated Adenomyosis'}, 'identificationModule': {'nctId': 'NCT03555903', 'acronym': 'ENDORAA', 'briefTitle': 'Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort', 'orgStudyIdInfo': {'id': '69HCL17_0813'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometriosis cohort', 'description': 'The aim of the study is to advance the scientific knowledge of deep infiltrating endometriosis (DIE) and to evaluate the impact of surgery on the quality of life and the fertility of affected women.', 'interventionNames': ['Other: Endometriosis cohort']}], 'interventions': [{'name': 'Endometriosis cohort', 'type': 'OTHER', 'description': 'The investigator record data on risks factors, symptoms (pain), quality of life (using standardized quality of life questionnaires), infertility history, and management of the disease with a 5-years follow up.\n\nDifferent surgical procedures exist to treat DIE and are they are described in the database, to allow comparison.', 'armGroupLabels': ['Endometriosis cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François GOLFIER, MD', 'role': 'CONTACT', 'email': 'francois.golfier@chu-lyon.fr', 'phone': '0478864179', 'phoneExt': '+33'}, {'name': 'Alix SESQUES, MD', 'role': 'CONTACT', 'email': 'alix.sesques@chu-lyon.fr'}, {'name': 'François GOLFIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alix SESQUES, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre-Adrien BOLZE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre hospitalier Lyon sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'François GOLFIER, MD', 'role': 'CONTACT', 'email': 'francois.golfier@chu-lyon.fr', 'phone': '0478864179', 'phoneExt': '+33'}, {'name': 'Alix SESQUES, MD', 'role': 'CONTACT', 'email': 'alix.sesques@chu-lyon.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}