GO SOAR1: Post-Operative Morbidity and Mortality Following Gynaecological Oncology Surgery

Surgery Clinical Trial

— GO SOAR1  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579861
• Other study ID #: 5009
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: NHS Grampian
• Contact: Faiza Gaba
• Phone: +441224 552604
• Email: faiza.gaba[@]nhs.scot
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gynecologic Cancer
• Neoplasms
• Surgery
• Surgery--Complications

Intervention

Other:
• Prospective data collection following gynaecological oncology surgery
Prospective data collection and entry on database following gynaecological oncology surgery

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen	County (optional)

Sponsors (8)

Lead Sponsor	Collaborator
Faiza Gaba	Cancer Diseases Hospital, European Network of Young Gynae Oncologists, NHS Grampian, Queen Mary University of London, Society of Gynecologic Oncology, University of Aberdeen, University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative surgical morbidity	Post-operative surgical morbidity	30 days
Primary	Post-operative surgical mortality	Post-operative surgical mortality	30 days