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Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04206696
Enrollment
384
Registered
2019-12-20
Start date
2010-07-01
Completion date
2019-01-01
Last updated
2019-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Invasive Surgery

Brief summary

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

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.

Interventions

None listed

Sponsors

The Second Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
operation timeBetween July 2010 and August 2016operation time in minutes
mortalityBetween July 2010 and August 2016mortality in percentage
lymphadenectomyBetween July 2010 and August 2016lymphadenectomy in number
bleeding volumeBetween July 2010 and August 2016bleeding volume in milliliter
complicationsBetween July 2010 and August 2016complications in percentage

Secondary

MeasureTime frameDescription
2-year overall survival rateBetween August 2016 and August 20182-year overall survival in percentage
2-year disease-free survivalBetween August 2016 and August 20182-year disease-free survival in percentage

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026