NCT04579861

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. 1.Set the research agenda through research prioritisation in gynaecological oncology surgical outcomes.
  2. 2.Gather high quality data via a centralised database accessible to all sites that perform gynaecological oncology surgery.
  3. 3.Build sustainable international research by producing protocols/guidelines.
  4. 4.Train the researchers and leaders of tomorrow by providing open access to all GO SOAR training materials.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

September 29, 2020

Last Update Submit

March 6, 2021

Conditions

Gynecologic CancerSurgerySurgery--Complications

Outcome Measures

Primary Outcomes (2)

  • Post-operative surgical morbidity

    Post-operative surgical morbidity

    30 days

  • Post-operative surgical mortality

    Post-operative surgical mortality

    30 days

Study Arms (2)

High human development

Countries classified as very high and high human development as per the United Nations development programme.

Other: Prospective data collection following gynaecological oncology surgery

Low and medium human development

Countries classified as low and medium human development as per the United Nations development programme.

Other: Prospective data collection following gynaecological oncology surgery

Interventions

Prospective data collection following gynaecological oncology surgeryOTHER

Prospective data collection and entry on database following gynaecological oncology surgery

High human developmentLow and medium human development

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women \>18 years undergoing gynaecological oncology surgery.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Grampian

Aberdeen, County (optional), United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34489356DERIVED

Study Officials

  • Faiza Gaba

    NHS Grampian

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faiza Gaba

CONTACT

+441224 552604faiza.gaba@nhs.scot

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Collaborative Lead & Chief Investigator

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 8, 2020

Study Start

January 19, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)