Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-01

Study Completion Date

2019-01-01

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.

Conditions

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Minimally Invasive Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaogang Zhao, Doctor

Role: STUDY_DIRECTOR

The Second Hospital of Shandong University

Other Identifiers

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MIE ZYP1

Identifier Type: -

Identifier Source: org_study_id