Pathophysiology, Mitigation, and a Core Outcome Set for the Empty Pelvis Syndrome After Pelvic Exenteration: a Delphi-study by the PelvEx Collaborative
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- A core outcome set for the empty pelvis syndrome
研究概览
简要总结
The empty pelvis syndrome is an unsolved and poorly defined problem severely affecting patients that have pelvic exenteration surgery, and also the teams looking after them. It is unclear what the anatomical and pathophysiological causes of the empty pelvis syndrome are, how it can be prevented, and how its sequelae can be measured. The evidence to guide decisions around the empty pelvis syndrome is of low quality, and so there is a large amount of variation in approaches between different hospitals.
This consensus study will define a core outcome set for the empty pelvis syndrome, and establish current levels of consensus on pathophysiology and mitigation of the empty pelvis syndrome through a modified-Delphi process involving both healthcare professionals and patient representatives.
详细描述
Rationale for a consensus study:
A measurable core outcome set for the empty pelvis syndrome will allow more directed research in this area. A core outcome set specifies a minimum set of outcomes to be measured for a particular health issue. Core outcome measures standardise and reduce bias in research. Selection of appropriate outcomes is essential in designing trials so that different treatments can be compared directly and efficiency, and therefore research in a particular area is improved. The Core Outcome Measures in Effectiveness Trials (COMET) database was searched on 14/07/2022 and there were no references to pelvic exenteration, complex pelvic cancers or the empty pelvis syndrome. Outcomes need to be relevant and important to stakeholders in a given problem, in the case of the empty pelvis syndrome this includes both patients and healthcare professionals. The study protocol presented here endeavours to address this gap in the literature, and has had involvement of patient representatives in its design.
In order to define and develop a core outcome set for the empty pelvis syndrome a modified-Delphi study is proposed. In addition to this consensus on the pathophysiology of the empty pelvis syndrome and which preventative reconstructive surgical techniques will be investigated.
The Expert Groups:
This Delphi study has been designed through The PelvEx Collaborative in accordance with the Guidance on Conducting and Reporting Delphi Studies (CREDES) guidelines, and The COMET Handbook. In order to undertake a Delphi study a panel of experts are required. The PelvEx Collaborative is a diverse international group of health care professionals from 140 hospitals across five continents that provide pelvic exenteration services, and aim to improve the results for patients after pelvic exenteration surgery. This is an ideal, motivated and logistically convenient platform to undertake a Delphi study due to its rich healthcare professional expert group and its access to patients as key stakeholders. In a Delphi study there is no agreement on how a group of experts should be selected, and there is no need for a statistically representative sample to be obtained. Therefore, all members of The PelvEx Collaborative will be invited to be involved in the study, generating, multi-professional, multi-national representation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare professional and member of The PelvEx Collaborative
- •Patient representative that has undergone pelvic exenteration surgery - defined as surgery to remove multiple organs from the pelvis, including beyond total mesorectal excision plane operations, for any pelvic malignancy (i.e., primary or recurrent colorectal, gynaecological, urological, and connective tissue disease)
- •Non-English speaking healthcare professionals and patient representatives where language translation is possible.
排除标准
- •Patient representatives that have not undergone pelvic exenteration surgery.
- •Non-English speaking healthcare professionals and patient representatives where language translation is not possible.
- •Individuals unable to take part in the online consensus process, or unable to give online consent digitally.
结局指标
主要结局
A core outcome set for the empty pelvis syndrome
时间窗: 8 months
Consensus process involving both healthcare professionals and patient representatives to define measurable outcomes for the empty pelvis syndrome
次要结局
- Consensus on mitigation of the empty pelvis syndrome using reconstructive techniques(8 months)
- Consensus on pathophysiology of the empty pelvis syndrome(8 months)