Traditional invasive versus minimally invasive esophagectomy.
Completed
- Conditions
- oesophagectomy, minimally invasive, open, cancer
- Registration Number
- NL-OMON20420
- Lead Sponsor
- VU university medical center
- Brief Summary
Biere SSAY, Cuesta MA, van der Peet DL. Minimally invasive versus open esophagectomy for cancer: a systematic review and meta-analysis. Minerva Chirurgica. 2009; 64: 121-133.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic oesophagus and Siewert I junction tumors which are surgically resectable (T1-3, N0-1, M0);
2. Treatment with neo-adjuvant therapy;
Exclusion Criteria
1. Carcinoma of the cervical oesophagus;
2. Prior thoracic surgery;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiratory complications (infections) within two weeks after the operation.
- Secondary Outcome Measures
Name Time Method 1. Operation related events (e.g. duration of operation, blood-loss);<br /><br>2. Re-operations;<br /><br>3. General morbidity (major and minor);<br /><br>4. Length of ICU and hospital stay (days);<br /><br>5. Type and number of analgesics needed after operation;<br /><br>6. VAS-pain-score;<br /><br>7. Return to fluid and normal diet;<br /><br>8. Quality of life questionnaires (SF-36 and EORTC QLQ-OES18);<br /><br>9. Quality of the specimen resected (e.g. length of specimen, number and location of lymph nodes resected and circumferential resection margin);<br /><br>10. Hospital mortality;<br /><br>11. Readmissions;<br /><br>12. Survival.