Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-07 @ 2:28 PM
Study NCT ID:
NCT03085732
Status:
UNKNOWN
Last Update Posted:
2017-03-21
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative infectious morbidities', 'timeFrame': '10 day after hysterectomy operation', 'description': 'vaginal cuff infection diagnosed with vagen cuff culture'}], 'secondaryOutcomes': [{'measure': 'gastrointestinal outcomes: nausea by questionnaire', 'timeFrame': 'postoperative first day', 'description': 'nausea by questionnaire'}, {'measure': 'gastrointestinal outcome: vomiting by questionnaire', 'timeFrame': 'postoperative first day', 'description': 'vomiting by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['saline irrigation', 'abdominal hysterectomy', 'postoperative infectious morbidities', 'gastrointestinal disturbances'], 'conditions': ['Gynecologic Surgery']}, 'descriptionModule': {'briefSummary': 'The objective of this prospective randomised clinic study is to investigate the effect of peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative infectious morbidities and gastrointestinal disturbance. The participants will be randomised to either an irrigation of abdominal cavity or the control group after vaginal closure. Assignment to one of the two treatment groups will be determined using a computer generated random numbers. Primary outcome is the rate of postoperative infectious morbidities. Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment arm planned.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing hysterectomies for benign causes\n\nExclusion Criteria:\n\n* patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess'}, 'identificationModule': {'nctId': 'NCT03085732', 'briefTitle': 'The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes', 'orgStudyIdInfo': {'id': 'Nadiye Koroglu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Irrigation with saline solution', 'description': 'during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done', 'interventionNames': ['Drug: Irrigation with Saline Solution']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'routine abdominal hysterectomy will be performed and no abdominal saline irrigation'}], 'interventions': [{'name': 'Irrigation with Saline Solution', 'type': 'DRUG', 'description': 'During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.', 'armGroupLabels': ['Irrigation with saline solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'nadiye koroglu', 'role': 'CONTACT', 'email': 'nadiye_dugan@hotmail.com', 'phone': '+905058065348'}], 'facility': 'Kanuni Sultan Suleyman Training and research hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nadiye Koroglu', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}