Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 11:14 AM
Study NCT ID:
NCT00484835
Status:
UNKNOWN
Last Update Posted:
2007-08-08
First Post:
2007-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-08-07', 'studyFirstSubmitDate': '2007-06-08', 'studyFirstSubmitQcDate': '2007-06-08', 'lastUpdatePostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operating time, Blood loss, Post-operative pain', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay, Cost of the procedure', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominal', 'Hysterectomy', 'Electrocoagulation forceps', 'Electrosurgery', 'Gyrus plasma open seal forceps', 'Patients undergoing abdominal hysterectomy for various reasons'], 'conditions': ['Total Abdominal Hysterectomy']}, 'descriptionModule': {'briefSummary': 'The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \\& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.', 'detailedDescription': 'Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps \\& the other group with the traditional clamp \\& suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.\n\nThe researcher will collect relevant data including age of patient, medical \\& surgical history and data relating to both the primary \\& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \\& cost.\n\nA qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.\n\nElectrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \\& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient already on waitlist in Southern Health for abdominal hysterectomy with suspected benign pathology\n\nExclusion Criteria:\n\n* Patients without consent and/or with suspected malignant pathology'}, 'identificationModule': {'nctId': 'NCT00484835', 'briefTitle': 'Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Southern Health'}, 'officialTitle': 'Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': 'Electrocoag Forceps in TAH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Performing abdominal hysterectomy using gyrus electrocoagulation forceps', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Casey Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Dandenong Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Marziya Kadir, MBBS', 'role': 'CONTACT', 'email': 'marziya@hotmail.com', 'phone': '613 95946666'}, {'name': 'Jason Tan, MBBS, MRANZCG', 'role': 'CONTACT', 'email': 'jasontan@iinet.net.au', 'phone': '61409116446'}], 'facility': 'Monash Medical Centre(Moorabin)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Marziya Kadir, MBBS', 'role': 'CONTACT', 'email': 'marziya@hotmail.com', 'phone': '613 95946666'}, {'name': 'Jason Tan, MBBS, MRANZCG', 'role': 'CONTACT', 'email': 'jasontan@iinet.net.au', 'phone': '61409116446'}], 'overallOfficials': [{'name': 'Marziya Kadir, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gyrus ACMI', 'class': 'INDUSTRY'}]}}}