Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT04579861
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2020-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GO SOAR1: Post-Operative Morbidity and Mortality Following Gynaecological Oncology Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-06', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-10-04', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative surgical morbidity', 'timeFrame': '30 days', 'description': 'Post-operative surgical morbidity'}, {'measure': 'Post-operative surgical mortality', 'timeFrame': '30 days', 'description': 'Post-operative surgical mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer', 'Surgery', 'Surgery--Complications']}, 'referencesModule': {'references': [{'pmid': '34489356', 'type': 'DERIVED', 'citation': 'Gaba F, Bizzarri N, Kamfwa P, Saiz A, Blyuss O, Paranjothy S, Ramirez PT, Cibula D; GO SOAR Team. Determining post-operative morbidity and mortality following gynecological oncology surgery: protocol for a multicenter, international, prospective cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative-GO SOAR). Int J Gynecol Cancer. 2021 Sep;31(9):1287-1291. doi: 10.1136/ijgc-2021-002586.'}]}, 'descriptionModule': {'briefSummary': 'The Global Gynaecological Oncology Surgical Outcomes Collaborative (GO SOAR) will develop a network of gynaecological oncology surgeons, surgical departments and other interested parties that will have the long-term ability to collaborate on outcome studies. The aims of the Collaborative are to:\n\n1. Set the research agenda through research prioritisation in gynaecological oncology surgical outcomes.\n2. Gather high quality data via a centralised database accessible to all sites that perform gynaecological oncology surgery.\n3. Build sustainable international research by producing protocols/guidelines.\n4. Train the researchers and leaders of tomorrow by providing open access to all GO SOAR training materials.\n\nThe Collaborative will lead to several studies.\n\nThe first GO SOAR collaborative study (GO SOAR1) will evaluate international variation of post-operative morbidity and mortality following gynaecological oncology surgery between country groups defined by the human development index (HDI).', 'detailedDescription': "Study hypothesis\n\nThere is no variation in post-operative morbidity and mortality rates following gynaecological oncology surgery between HDI country groups.\n\nRegulatory approval\n\nQuality Improvement \\& Assurance Team, Research and Development NHS Grampian (Project ID 5009).\n\nStudy design\n\nInternational, multi-centre, prospective cohort study.\n\nPrimary objectives\n\n1\\. To evaluate international variation of post-operative morbidity and mortality following gynaecological oncology surgery between country groups defined by HDI.\n\nSecondary objectives\n\n1. To evaluate international variation between HDI country groups of intra-operative morbidity and mortality following gynaecological oncology surgery.\n2. To evaluate international variation between HDI country groups of histological clearance rates of gynaecological malignancies.\n3. To establish an international gynaecological oncology collaborative and surgical outcomes database.\n4. To identify modifiable surgical processes.\n5. To establish best practices and standards for gynaecological oncology surgery.\n6. To champion promotion of quality improvement and research and gynaecological oncology surgical training.\n\nInterventions\n\nPatient data will be collected over a consecutive thirty day period through gynaecological oncology multidisciplinary teams/tumour boards and clinics across different human development index country groups. Additional data entry (beyond thirty days) is encouraged and may take place at the discretion of the participating site. All patients are followed up as per local protocols for thirty days post-operatively to identify post-surgical morbidity/mortality. For each patient, data will be captured on demographic variables, centre/unit/hospital site, FIGO staging, surgical modality, intra-operative morbidity/mortality, 30 day morbidity/mortality following surgery, tumour resectability, access to diagnostic endoscopy/hysteroscopy, histopathology/radiological imaging/laboratories/critical care facilities, multidisciplinary team/tumour board meetings, chemotherapy, radiotherapy seniority and training of lead surgeon. All data is collected on a customised, secure, password protected central REDCap database.\n\nFollow up\n\nAll investigators are required to monitor patients for thirty days post-operatively to identify complications. Most of these events are expected to occur during the individual's inpatient stay. Centres must be proactive in identifying post-operative events (or an absence of them), within the limits of normal follow up. Local arrangements may include:\n\n1. Daily review of patient status and notes before discharge to identify inpatient complications.\n2. Reviewing the patient status at a post-surgery follow up appointment in an outpatient clinic or via telephone (if this is normal practice).\n3. Checking hospital records (electronic/paper) or handover lists for re-attendances/re-admissions.\n4. Checking for Emergency Department re-attendances.\n5. Contacting general/family practitioners to enquire about complications managed in primary care.\n\nInternational Steering Committee\n\nAn international steering committee will oversee the study. The committee will monitor and supervise progress and adherence to protocol. The committee will review at regular intervals relevant information from other sources, e.g. other audits/studies. It will ensure that the study is conducted to a high standard in line with Guidelines for Good Clinical Practice. The committee will meet every six months though more frequent meetings may be called if necessary. Meetings will be called for by the chief investigator."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women \\>18 years undergoing gynaecological oncology surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged \\>18 years undergoing curative, curative attempted but then abandoned (i.e. open/close laparotomy) or palliative surgery for primary tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies.\n2. Surgery for recurrent primary tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies.\n3. Open, minimal access (laparoscopic/robotic), minimal access converted to open or vaginal surgeries for tubo-ovarian/peritoneal, endometrial, cervical, vulval, vagina, gestational trophoblastic malignancies.\n4. Elective and emergency surgeries.\n5. Surgeries where pre-operative pathology thought to be benign but malignancy confirmed on histopathology post-operatively.\n\nExclusion Criteria:\n\n1. Surgeries where pre-operative pathology thought to be malignant but benign disease confirmed on histopathology post-operatively.\n2. Non gynaecological disease as the primary malignancy.\n3. Diagnostic procedures (e.g. staging laparoscopy, image guided biopsy).\n4. Any procedure not requiring a skin incision under general/regional anaesthesia (e.g. chemotherapy, radiotherapy, hysteroscopy).'}, 'identificationModule': {'nctId': 'NCT04579861', 'acronym': 'GO SOAR1', 'briefTitle': 'GO SOAR1: Post-Operative Morbidity and Mortality Following Gynaecological Oncology Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Grampian'}, 'officialTitle': 'Determining Post-operative Morbidity and Mortality Following Gynaecological Oncology Surgery: a Multicentre, International, Prospective Cohort Study Led by the Global Gynaecological Oncology Surgical Outcomes Collaborative (GO SOAR)', 'orgStudyIdInfo': {'id': '5009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High human development', 'description': 'Countries classified as very high and high human development as per the United Nations development programme.', 'interventionNames': ['Other: Prospective data collection following gynaecological oncology surgery']}, {'label': 'Low and medium human development', 'description': 'Countries classified as low and medium human development as per the United Nations development programme.', 'interventionNames': ['Other: Prospective data collection following gynaecological oncology surgery']}], 'interventions': [{'name': 'Prospective data collection following gynaecological oncology surgery', 'type': 'OTHER', 'description': 'Prospective data collection and entry on database following gynaecological oncology surgery', 'armGroupLabels': ['High human development', 'Low and medium human development']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aberdeen', 'state': 'County (optional)', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Faiza Gaba', 'role': 'CONTACT', 'email': 'faiza.gaba@nhs.scot'}], 'facility': 'NHS Grampian', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'centralContacts': [{'name': 'Faiza Gaba', 'role': 'CONTACT', 'email': 'faiza.gaba@nhs.scot', 'phone': '+441224 552604'}], 'overallOfficials': [{'name': 'Faiza Gaba', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Grampian'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faiza Gaba', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Aberdeen', 'class': 'OTHER'}, {'name': 'University of Hertfordshire', 'class': 'OTHER'}, {'name': 'NHS Grampian', 'class': 'OTHER_GOV'}, {'name': 'Queen Mary University of London', 'class': 'OTHER'}, {'name': 'European Network of Young Gynae Oncologists', 'class': 'UNKNOWN'}, {'name': 'Society of Gynecologic Oncology', 'class': 'OTHER'}, {'name': 'Cancer Diseases Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Collaborative Lead & Chief Investigator', 'investigatorFullName': 'Faiza Gaba', 'investigatorAffiliation': 'NHS Grampian'}}}}