REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 17
- 主要终点
- Work package 1
研究概览
简要总结
Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect.
Reconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes.
REMACS has three work packages:
- Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures.
- A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity.
- A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries.
The last two work packages have now been funded by an NIHR Research for Patient Benefit Grant
详细描述
This is an observational multicentre retrospective and prospective cohort study, and a qualitative study. The project will have three working packages:
- Work package 1 - maintenance of a colorectal surgery database
- Work package 2 - prospective collaborative national UK study
- Work package 3 - qualitative analysis with semi-structured interviews
WORK PACKAGE 1 - COLORECTAL SURGERY DATABASE:
Data collected includes:
- Basic demographic information
- Co-morbidities at time of surgery
- Other cancer treatments
- Final cancer staging and diagnosis
- Type of procedure
- Methods of reconstruction
- Use of healthcare resource: (theatre time, surgical teams, use of consumables, index operation intensive care stay, total length of stay, planned or emergency readmissions, use of imaging for complications, re-interventions, and outpatient clinic use).
- Morbidity - empty pelvis syndrome complications with collation of all complications that occurred summarised into: (the highest Clavien-Dindo (CD) score, and the comprehensive complication index by accumulating CD graded complications that a patient has as a result of their surgery.
- Survival: overall and disease-free survival
- Patient reported outcome measures
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 or older
- •Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database)
- •Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study)
- •Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study)
排除标准
- •Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery
- •Patients that undergo surgery by an intersphincteric abdominoperineal resection approach
- •Patients that are unable to complete the questionnaire over the telephone or online with a researcher
- •Patients unable or unwilling to provide informed consent
- •Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service
结局指标
主要结局
Work package 1
时间窗: Data collection from prospectively maintained databases over 10 years
Morbidity for patients undergoing perineal reconstruction following abdominoperineal excision or pelvic exenteration, established by documenting empty pelvis syndrome complications and overall Clavien Dindo scores
Work package 2
时间窗: 12 months
Establishing quality of life in patients undergoing perineal reconstruction with for abdominoperineal excision and pelvic exenteration using The Global European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores. Note Global EORTC QLQ-C30 Score ranges from 0 - 100, with a higher score indicating a higher quality of life.
Work package 3
时间窗: 3 and 12 months post surgery
Undertake qualitative analysis from patients' accounts of their experiences in semi-structured interview, in order to complete a more complex evaluation of quality of life after pelvic exenteration and abdominoperineal resection.
次要结局
- Work package 1(Retrospective data collection over 10 years)
- Work package 2(12 months)
- Work Package 2(24 months)
- Work package 3(3 and 12 months after surgery)