Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 3
- 主要终点
- Change from baseline in SF36 Quality of Life Questionnaire at 24 month
研究概览
简要总结
To assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. To compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (QOL). To look at the applicability of this QOL instrument to this patient group.
详细描述
Assess short and long term outcomes after minimally invasive esophagectomy(MIE) compared to open esophagectomy. Measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (QOL) using the MOS SF36 questionnaire. Evaluate whether the SF36 will accurately reflect pre and postoperative changes in clinical status in this patient group.Compare the results of this global QOL instrument (SF 36) to disease specific scales of dysphagia and reflux. Assess the impact of adjuvant or neoadjuvant therapy on QOL in this patient group and determine if any advantages of MIE can be demonstrated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients scheduled for MIE (Minimally Invasive Esophagectomy)
- •Patients scheduled for open esophagectomy
- •Signed informed consent
排除标准
- •Patients who are unable to comprehend or complete the QOL instruments.
- •Patients less than 18 years of age.
结局指标
主要结局
Change from baseline in SF36 Quality of Life Questionnaire at 24 month
时间窗: Baseline and 24 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 6 month postoperative
时间窗: Baseline and 6 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 30 month
时间窗: Baseline and 30 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 12 month postoperative
时间窗: Baseline and 12 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 18 month
时间窗: Baseline and 18 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 36 month
时间窗: Baseline and 36 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
Change from baseline in SF36 Quality of Life Questionnaire at 4 month postoperative
时间窗: Baseline and 4 month postoperative
The SF36 is an eight dimension Quality of Life Measurement. It provides two main Component scores, Physical Component Summary (PCS) and the Mental Component Summary (MCS). It includes 8 scales or sub-scores: Physical function (PF), role physical (RP), Bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MG). Each scale contributes a different amount to the component scores, which are calculated by a special algorithm that is licensed by Optum. The Component and sub-scales have a minimum of 0 and a maximum of 100. The higher the score represent the higher quality of life/less disability.
次要结局
未报告次要终点
研究者
James Luketich
MD
University of Pittsburgh