Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Study Overview
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Brief Summary
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Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.

Detailed Description
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Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The Second Hospital of Shandong University. Eight of these 214 patients were converted to thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to a history of left upper lobectomy, and the other seven patients were due to bleeding controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014 to August 2016, and these patients were defined as the open group. The data from the patients in the open group were compared with those of the patients who underwent thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography to evaluate the clinical TNM stage. The operations were performed by a single surgical team. This study was approved by the ethics committee and Medical Administration Division of the Second Hospital of Shandong University. Written informed consent was obtained from each of the enrolled patients. All methods performed in the investigator's study were conducted in accordance with the relevant guidelines and regulations.

Official Title
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Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Conditions
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Minimally Invasive Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery Exclusion Criteria: poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection

Ages Eligible for Study
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Minimum Age: 40 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding volume | bleeding volume in milliliter | Between July 2010 and August 2016 | 
| operation time | operation time in minutes | Between July 2010 and August 2016 | 
| complications | complications in percentage | Between July 2010 and August 2016 | 
| mortality | mortality in percentage | Between July 2010 and August 2016 | 
| lymphadenectomy | lymphadenectomy in number | Between July 2010 and August 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year overall survival rate | 2-year overall survival in percentage | Between August 2016 and August 2018 | 
| 2-year disease-free survival | 2-year disease-free survival in percentage | Between August 2016 and August 2018 |