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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Post-operative surgical morbidity
研究概览
简要总结
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:
- Set the research agenda through research prioritisation in gynaecological oncology surgical outcomes.
- Gather high quality data via a centralised database accessible to all sites that perform gynaecological oncology surgery.
- Build sustainable international research by producing protocols/guidelines.
- 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).
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Post-operative surgical morbidity
时间窗: 30 days
Post-operative surgical morbidity
Post-operative surgical mortality
时间窗: 30 days
Post-operative surgical mortality
次要结局
未报告次要终点
研究者
Faiza Gaba
Collaborative Lead & Chief Investigator
NHS Grampian