Subjective Functional Outcome After Oesophagectomy With and Without Anastomotic Leak
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ)
研究概览
简要总结
The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.
详细描述
The investigators will select patients after oesophagectomy and perform a structured interview regarding their quality of life and subjective swallow function. Results will be compared according to defined subgroups, especially patients with and without anastomotic leak.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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 who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
- •Patients older than 18 years
排除标准
- •Patients with achalasia
- •inability to understand study procedure or to provide informed consent
研究组 & 干预措施
Anastomotic leak
Patients who had an Ivor Lewis Oesophagectomy and suffered an anastomotic leak (AL) postoperatively. AL, as defined according to ECCG (Esophagectomy Complication Consensus Group) criteria 1-3.
干预措施: Anastomotic Leak after Ivor Lewis Oesophagectomy (Procedure)
No anastomotic leak
Patients who had an Ivor Lewis Oesophagectomy and had no AL postoperatively, ECCG 0.
结局指标
主要结局
Swallow function by questionnaires: Sydney Swallow Questionnaire (SSQ)
时间窗: earliest 6 months postoperatively
This questionnaire consists of 17 questions and is mainly based on a visual analog scale (VAS) to assess functional swallowing. The sum of all questions ranges from 0-1700. The calculated upper limit of the reference interval is 234 in a non-dysphagic population. A higher score represents a more severe dysphagia.
Swallow function by questionnaires: Brief Esophageal Dysphagia Questionnaire (BEDQ)
时间窗: earliest 6 months postoperatively
The BEDQ has 10 questions to score dysphagia specifically. The questions are answered using a Likert scale (low to high), which sums up to a score ranging from 0 (asymptomatic) to 40.
Swallow function by questionnaires: Eckardt Score (ES)
时间窗: earliest 6 months postoperatively
The ES is a questionnaire with four items (weight loss, chest pain, regurgitation, and dysphagia) initially used to evaluate achalasia. The maximum score is 12; the higher the score, the more trouble patients have with swallowing.
次要结局
- Quality of life by questionnaires EORTC-OG25 (Oesophagogastric-25)(earliest 6 months postoperatively)
- Quality of life by questionnaires EORTC-C30 (European Organisation for Research and Treatment of Cancer-Cancer 30)(earliest 6 months postoperatively)
研究者
Stefan Gutknecht
Principal Investigator
Stadtspital Zürich