Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT07146659
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-07-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This will be assessed as an ordinal qualitative variable, with procedures classified into three categories:number of complete success, number of partial success, or number of failure.', 'timeFrame': 'The classification will be determined by the surgeon at the end of the procedure and documented in the operative report (baseline)'}], 'secondaryOutcomes': [{'measure': 'Perioperative and postoperative pain Assessed using the Visual Analogue Scale (VAS)', 'timeFrame': 'During the procedure (if the patient is awake), immediately after the procedure, and at hospital discharge (baseline)'}, {'measure': 'Patient satisfaction Assessed using a locally developed patient satisfaction questionnaire', 'timeFrame': 'At hospital discharge.(assessed up to 5 days)'}, {'measure': 'Complications including uterine perforation, hemorrhage, and postoperative infection', 'timeFrame': 'Recorded during the procedure and immediately afterward (documented in the operative report and medical records), and up to 8 weeks postoperatively during the follow-up consultation if necessary.'}, {'measure': '4. Time to return to work Measured as the number of days of sick leave prescribed and actually taken.', 'timeFrame': 'Up to 8 weeks postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysteroscopy', 'Operative hysteroscopy', 'Outpatient ambulatory', 'Patient satisfaction', 'Outpatient hysteroscopy', 'Complications'], 'conditions': ['Fibroid Uterus', 'Polyp Uterus', 'Retained Products of Conception']}, 'descriptionModule': {'briefSummary': 'This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return to work.', 'detailedDescription': 'Operative hysteroscopy is a key technique for the treatment of intrauterine pathologies such as endometrial polyps, submucosal fibroids, retained products of conception. Traditionally, operative hysteroscopies are performed in the operating room under general or regional anesthesia, requiring either ambulatory or inpatient hospitalization.\n\nIn recent years, advances in hysteroscopic instrumentation and procedural techniques have made it possible to perform selected operative hysteroscopies in outpatient settings (consultation office) without general or regional anesthesia. Several studies have demonstrated the feasibility, safety, and effectiveness of outpatient operative hysteroscopy, with similar success rates and complication profiles compared to procedures performed in the operating room, although some studies reported higher levels of pain during outpatient procedures (1-3) . Furthermore, cost-effectiveness studies support outpatient procedures by highlighting reduced hospital resource utilization and shorter recovery times for patients (4-6).\n\nThe HOPE study aims to evaluate this practice locally at the Centre Hospitalier Intercommunal de Créteil. This prospective monocentric observational study will include approximately 400 patients over a two-year period (July 2025 - May 2027). The primary objective is to compare the success rates of operative hysteroscopies performed in the operating room versus those performed in an outpatient setting. Secondary objectives include assessment of perioperative and postoperative pain, patient satisfaction, complication rates, and the time to return to work.\n\nData will be collected from medical records and patient-reported outcomes using a satisfaction questionnaire. Inclusion of patients will follow the usual care pathway, without additional interventions or follow-up beyond standard clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women requiring operative hysteroscopy for intrauterine pathology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged ≥ 18 years\n\n -⁃ Undergoing operative hysteroscopy for intrauterine pathology\n* Able to provid e informed non-opposition\n* French-speaking\n\nExclusion Criteria:\n\n* Patients with contraindications to hysteroscopy\n* Pregnancy\n* Inability to complete follow-up'}, 'identificationModule': {'nctId': 'NCT07146659', 'briefTitle': 'Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings : A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'HOPE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operative hysteroscopy in the operating room', 'description': 'Operative hysteroscopy in the operating room: Procedures performed under general or regional anesthesia in a surgical setting (either ambulatory or conventional hospitalization).'}, {'label': 'Operative hysteroscopy in the outpatient setting', 'description': 'Operative hysteroscopy in the outpatient setting: Procedures performed in a consultation room without general or regional anesthesia, using local anesthesia if needed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann SALHI, MD', 'role': 'CONTACT', 'email': 'yann.salhi@chicreteil.fr'}, {'name': 'Elie MOSNINO, MD', 'role': 'CONTACT', 'email': 'elie.mosnino@gmail.com'}], 'facility': 'CHI Créteil - Gynécologie et obstétrique', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Yann SALHI, MD', 'role': 'CONTACT', 'email': 'yann.salhi@chicreteil.fr', 'phone': '0157022000', 'phoneExt': '8456'}, {'name': 'Elie MOSNINO, MD', 'role': 'CONTACT', 'email': 'elie.mosnino@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}