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:
Faiza Gaba
Organization:
Study Overview
Official Title:
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)
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GO SOAR1
Brief Summary:
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:
1. Set the research agenda through research prioritisation in gynaecological oncology surgical outcomes.
2. Gather high quality data via a centralised database accessible to all sites that perform gynaecological oncology surgery.
3. Build sustainable international research by producing protocols/guidelines.
4. Train the researchers and leaders of tomorrow by providing open access to all GO SOAR training materials.
The Collaborative will lead to several studies.
The 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).
1. Set the research agenda through research prioritisation in gynaecological oncology surgical outcomes.
2. Gather high quality data via a centralised database accessible to all sites that perform gynaecological oncology surgery.
3. Build sustainable international research by producing protocols/guidelines.
4. Train the researchers and leaders of tomorrow by providing open access to all GO SOAR training materials.
The Collaborative will lead to several studies.
The 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).
Detailed Description:
Study hypothesis
There is no variation in post-operative morbidity and mortality rates following gynaecological oncology surgery between HDI country groups.
Regulatory approval
Quality Improvement \& Assurance Team, Research and Development NHS Grampian (Project ID 5009).
Study design
International, multi-centre, prospective cohort study.
Primary objectives
1\. To evaluate international variation of post-operative morbidity and mortality following gynaecological oncology surgery between country groups defined by HDI.
Secondary objectives
1. To evaluate international variation between HDI country groups of intra-operative morbidity and mortality following gynaecological oncology surgery.
2. To evaluate international variation between HDI country groups of histological clearance rates of gynaecological malignancies.
3. To establish an international gynaecological oncology collaborative and surgical outcomes database.
4. To identify modifiable surgical processes.
5. To establish best practices and standards for gynaecological oncology surgery.
6. To champion promotion of quality improvement and research and gynaecological oncology surgical training.
Interventions
Patient 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.
Follow up
All 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:
1. Daily review of patient status and notes before discharge to identify inpatient complications.
2. Reviewing the patient status at a post-surgery follow up appointment in an outpatient clinic or via telephone (if this is normal practice).
3. Checking hospital records (electronic/paper) or handover lists for re-attendances/re-admissions.
4. Checking for Emergency Department re-attendances.
5. Contacting general/family practitioners to enquire about complications managed in primary care.
International Steering Committee
An 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.
There is no variation in post-operative morbidity and mortality rates following gynaecological oncology surgery between HDI country groups.
Regulatory approval
Quality Improvement \& Assurance Team, Research and Development NHS Grampian (Project ID 5009).
Study design
International, multi-centre, prospective cohort study.
Primary objectives
1\. To evaluate international variation of post-operative morbidity and mortality following gynaecological oncology surgery between country groups defined by HDI.
Secondary objectives
1. To evaluate international variation between HDI country groups of intra-operative morbidity and mortality following gynaecological oncology surgery.
2. To evaluate international variation between HDI country groups of histological clearance rates of gynaecological malignancies.
3. To establish an international gynaecological oncology collaborative and surgical outcomes database.
4. To identify modifiable surgical processes.
5. To establish best practices and standards for gynaecological oncology surgery.
6. To champion promotion of quality improvement and research and gynaecological oncology surgical training.
Interventions
Patient 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.
Follow up
All 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:
1. Daily review of patient status and notes before discharge to identify inpatient complications.
2. Reviewing the patient status at a post-surgery follow up appointment in an outpatient clinic or via telephone (if this is normal practice).
3. Checking hospital records (electronic/paper) or handover lists for re-attendances/re-admissions.
4. Checking for Emergency Department re-attendances.
5. Contacting general/family practitioners to enquire about complications managed in primary care.
International Steering Committee
An 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: