Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01442961
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2011-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D007045', 'term': 'Hysterectomy, Vaginal'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007044', 'term': 'Hysterectomy'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-09', 'studyFirstSubmitDate': '2011-09-19', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative consumption of an opioid (oxycodone)', 'timeFrame': '20 hours', 'description': 'the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump'}], 'secondaryOutcomes': [{'measure': 'NRS (numeral rating scale) of pain', 'timeFrame': '20 hours', 'description': 'NRS is evaluated frequently during the study period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain, postoperative', 'hysterectomy, vaginal', 'surgery, gynecological'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 -69 years\n* Gender . female\n* ASA status 1-3\n* Vaginal hysterectomy or laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* Body mass Index over 35\n* Diabetes Mellitus\n* Liver disease\n* Allergies to pharmaceuticals used in the Study\n* Present use of opioids\n* Vaginal prolapse'}, 'identificationModule': {'nctId': 'NCT01442961', 'briefTitle': 'Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial', 'orgStudyIdInfo': {'id': 'R09003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopy', 'description': 'Intervention: Procedure: laparoscopy', 'interventionNames': ['Procedure: laparoscopy, laparoscopic hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal', 'description': 'Intervention: Procedure: vaginal', 'interventionNames': ['Procedure: vaginal : vaginal hysterectomy']}], 'interventions': [{'name': 'laparoscopy, laparoscopic hysterectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic hysterectomy', 'armGroupLabels': ['laparoscopy']}, {'name': 'vaginal : vaginal hysterectomy', 'type': 'PROCEDURE', 'description': 'Vaginal hysterectomy', 'armGroupLabels': ['vaginal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Arvi Yli-Hankala', 'investigatorAffiliation': 'Tampere University Hospital'}}}}