Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT05784493
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain After Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessed by visual analog scale', 'timeFrame': '5 months', 'description': 'To assess postoperative pain incidence by using visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.', 'detailedDescription': 'The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.\n\nThis study is double blind randomized controlled study.\n\ninclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition\n\nexclusion criteria: maling cases and conversion to laparotomy\n\nafter randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all of cases that had laparoscopic hysterectomy for bening conditions\n\nExclusion Criteria:\n\n* maling cases\n* conversion to laparotomy'}, 'identificationModule': {'nctId': 'NCT05784493', 'briefTitle': 'Pain After Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2020.04.06.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Washing by heated saline group', 'interventionNames': ['Other: Study group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Washing by normal room temperature saline group', 'interventionNames': ['Other: Study group']}], 'interventions': [{'name': 'Study group', 'type': 'OTHER', 'description': 'Washing by heated saline group', 'armGroupLabels': ['Washing by heated saline group', 'Washing by normal room temperature saline group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tekirdağ', 'country': 'Turkey (Türkiye)', 'facility': 'Namik Kemal University', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fırat Can Sogut', 'class': 'UNKNOWN'}, {'name': 'Ozlem Sevinc Ergul', 'class': 'UNKNOWN'}, {'name': 'Mehmet Veysel Arın', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pirincipal İnvestigator', 'investigatorFullName': 'Mehmet Baki Senturk', 'investigatorAffiliation': 'Namik Kemal University'}}}}