Health-related Quality of Life of Patients With Esophageal Cancer After Surgery

Study Overview
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Brief Summary
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The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.

Detailed Description
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To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery. To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer. To compare morbidities and oncological results(3,5- year survival) from different procedures.

Official Title
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Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: MIE
* Procedure: Three-incision thoracotomy
* Procedure: Ivor-Lewis esophagectomy
* Procedure: Sweet esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical stage I/II esophageal cancer Normal blood test of basic metabolism panel Pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50% Heart function: NY grade I and grade II Exclusion Criteria: Mental disorders Combination with other cancers With a previous history of thoracic or ventral surgery

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MIE Group<br>The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic) | Procedure: MIE<br>* The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)<br>* Other names: esophagectomy;|
| Other: Three-incision esophagectomy group<br>The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy) | Procedure: Three-incision thoracotomy<br>* The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)<br>* Other names: esophagectomy;|
| Other: Ivor-Lewis esophagectomy group<br>The patients in this group would underwent Ivor-Lewis esophagectomy | Procedure: Ivor-Lewis esophagectomy<br>* The patients in this group would underwent Ivor-Lewis esophagectomy<br>* Other names: esophagectomy;|
| Other: Sweet esophagectomy group<br>The patients in this group would underwent Sweet esophagectomy. | Procedure: Sweet esophagectomy<br>* The patients in this group would underwent Sweet esophagectomy.<br>* Other names: esophagectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18) | postoperative 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity Mortality Survival rate | Perioperative morbidity and mortality from the different precedure groups. 3-and 5-year survival rate between the groups. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health-related quality of life(HRQL), Esophageal Cancer