Clinical trial NCT04579861: GO SOAR1: Post-Operative Morbidity and Mortality Following Gynaecological Oncology Surgery
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Cancer
Surgery
Surgery--Complications
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
Collaborators: name: University of Aberdeen
name: University of Hertfordshire
name: NHS Grampian
name: Queen Mary University of London
name: European Network of Young Gynae Oncologists
name: Society of Gynecologic Oncology
name: Cancer Diseases Hospital
First posted: 2020-10-08
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women \>18 years undergoing gynaecological oncology surgery.

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).

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Surgery for recurrent primary tubo-ovarian/peritoneal, endometrial, cervical, vulval, vaginal, gestational trophoblastic malignancies.
3. Open, minimal access (laparoscopic/robotic), minimal access converted to open or vaginal surgeries for tubo-ovarian/peritoneal, endometrial, cervical, vulval, vagina, gestational trophoblastic malignancies.
4. Elective and emergency surgeries.
5. Surgeries where pre-operative pathology thought to be benign but malignancy confirmed on histopathology post-operatively.

Exclusion Criteria:

1. Surgeries where pre-operative pathology thought to be malignant but benign disease confirmed on histopathology post-operatively.
2. Non gynaecological disease as the primary malignancy.
3. Diagnostic procedures (e.g. staging laparoscopy, image guided biopsy).
4. Any procedure not requiring a skin incision under general/regional anaesthesia (e.g. chemotherapy, radiotherapy, hysteroscopy).

Primary outcomes:
measure: Post-operative surgical morbidity
timeFrame: 30 days
measure: Post-operative surgical mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
state: County (optional)
Study officials:
affiliation: NHS Grampian
name: Faiza Gaba
role: PRINCIPAL_INVESTIGATOR
References:
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.