Minimally Invasive Surgery Clinical Trial
Official title:
Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
NCT number | NCT04206696 |
Other study ID # | MIE ZYP1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2010 |
Est. completion date | January 1, 2019 |
Verified date | December 2019 |
Source | The Second Hospital of Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 384 |
Est. completion date | January 1, 2019 |
Est. primary completion date | August 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Second Hospital of Shandong University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bleeding volume | bleeding volume in milliliter | Between July 2010 and August 2016 | |
Primary | operation time | operation time in minutes | Between July 2010 and August 2016 | |
Primary | complications | complications in percentage | Between July 2010 and August 2016 | |
Primary | mortality | mortality in percentage | Between July 2010 and August 2016 | |
Primary | lymphadenectomy | lymphadenectomy in number | Between July 2010 and August 2016 | |
Secondary | 2-year overall survival rate | 2-year overall survival in percentage | Between August 2016 and August 2018 | |
Secondary | 2-year disease-free survival | 2-year disease-free survival in percentage | Between August 2016 and August 2018 |
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