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

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ClinicalTrials.gov Identifier: NCT04579861
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
University of Aberdeen
University of Hertfordshire
NHS Grampian
Queen Mary University of London
European Network of Young Gynae Oncologists
Society of Gynecologic Oncology
Cancer Diseases Hospital
Information provided by (Responsible Party):
Faiza Gaba, NHS Grampian

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).


Condition or disease Intervention/treatment
Gynecologic Cancer Surgery Surgery--Complications Other: Prospective data collection following gynaecological oncology surgery

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
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
Prospective data collection and entry on database 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
Prospective data collection and entry on database following gynaecological oncology surgery




Primary Outcome Measures :
  1. Post-operative surgical morbidity [ Time Frame: 30 days ]
    Post-operative surgical morbidity

  2. Post-operative surgical mortality [ Time Frame: 30 days ]
    Post-operative surgical mortality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women >18 years undergoing gynaecological oncology surgery.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579861


Contacts
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Contact: Faiza Gaba +441224 552604 faiza.gaba@nhs.scot

Locations
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United Kingdom
NHS Grampian Recruiting
Aberdeen, County (optional), United Kingdom
Contact: Faiza Gaba       faiza.gaba@nhs.scot   
Sponsors and Collaborators
Faiza Gaba
University of Aberdeen
University of Hertfordshire
NHS Grampian
Queen Mary University of London
European Network of Young Gynae Oncologists
Society of Gynecologic Oncology
Cancer Diseases Hospital
Investigators
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Principal Investigator: Faiza Gaba NHS Grampian
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Responsible Party: Faiza Gaba, Collaborative Lead & Chief Investigator, NHS Grampian
ClinicalTrials.gov Identifier: NCT04579861    
Other Study ID Numbers: 5009
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms