Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-03-27 @ 6:05 PM
Study NCT ID:
NCT02367703
Status:
UNKNOWN
Last Update Posted:
2015-09-22
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-18', 'studyFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'at day 1 (at the end of the surgery)'}], 'secondaryOutcomes': [{'measure': 'quantity of intraoperative bleeding', 'timeFrame': 'at day 1 (at the end of the intervention)'}, {'measure': 'hemoglobin', 'timeFrame': 'at day 1'}, {'measure': 'Pain Rating Scale (VAS)', 'timeFrame': 'at day 1 (at 6 hours potoperative hours)'}, {'measure': 'Pain Rating Scale (VAS)', 'timeFrame': 'at day 1 (at 24 postoperative hours)'}, {'measure': 'standard laparoscopy conversion rate', 'timeFrame': 'at day 1'}, {'measure': 'postoperative complications', 'timeFrame': 'at each additional hospitalisation', 'description': 'postoperative complications according Accordion Severity Classification score (grade\\> or = 2) listed at each additional hospitalisation'}, {'measure': 'Patient Scar Assessment Scale (PSAS)', 'timeFrame': 'at 6 and 8 weeks after surgery.', 'description': 'Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation'}, {'measure': "Surgen's ergonomics", 'timeFrame': 'at the end of the surgery', 'description': "Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)"}]}, 'conditionsModule': {'keywords': ['Mini-laparoscopy', 'hysterectomy', 'Benign uterine diseases', 'Operative time'], 'conditions': ['Benign Uterine Diseases']}, 'descriptionModule': {'briefSummary': "Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.", 'detailedDescription': "That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.\n\nThe study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.\n\nThe day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).\n\nThe day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.\n\nAt Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.\n\nAt the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and\n* benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.\n\nand\n\n* affiliation to social security and\n* informed consent\n\nExclusion Criteria:\n\n* ASA III or IV patients,\n* age\\> 80 years old,\n* history of major abdominal surgery by laparotomy\n* severe obesity (BMI\\> 35kg / m2)\n* pathology of hemostasis and coagulation (liver disease, bleeding disorders)\n* uterine volume estimated on preoperative ultrasonography \\> 300 g\n* minor patients,\n* adult lacking legal capacity\n* patients suffering from mental illness incompatible with informed consent, refusal to participate.'}, 'identificationModule': {'nctId': 'NCT02367703', 'briefTitle': "Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': "Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study", 'orgStudyIdInfo': {'id': 'CHU-0223'}, 'secondaryIdInfos': [{'id': '2014-A01698-39', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard instrument', 'description': "That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy", 'interventionNames': ['Procedure: laparoscopic hysterectomy']}, {'type': 'OTHER', 'label': "less than 3 millimeter diameter's instruments", 'description': "That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy", 'interventionNames': ['Procedure: laparoscopic hysterectomy']}], 'interventions': [{'name': 'laparoscopic hysterectomy', 'type': 'PROCEDURE', 'armGroupLabels': ["less than 3 millimeter diameter's instruments", 'standard instrument']}]}, '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'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Revaz BOTCHORISHVILI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'STORZ® laboratory', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}