SHARE study: A randomized controlled trial comparing a semimechanical with a hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.
Recruiting
- Conditions
- Oesophageal cancer, esophagectomy, anastomosis, end-to-end, semi-mechanical, leakage, stenosis
- Registration Number
- NL-OMON24371
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Esophageal resection with stomach tube reconstruction for esophageal carcinoma;
2. Cervical anastomosis;
Exclusion Criteria
1. Other forms of esophageal reconstruction than a stomach tube;
2. Upper thoracic/cervical esophageal cancer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: <br /><br>Clinical anastomotic leakage defined by neck wound infection and loss of saliva and/or ingested fluids through the wound site, signs of mediastinitis or intrathoracic abcess or leakage confirmed by radiological examination (endoscopy or CT with contrast fluids) after clinical suspicion (i.e. leucocytosis, fever, pain), all within 30 days after operation.
- Secondary Outcome Measures
Name Time Method 1. Anastomotic stricture within one year;<br /><br>2. Number of dilations within one year;<br /><br>3. Dysphagia score (table 1, score by Sugahara);<br /><br>4. Quality of life measured by EORTC QLQ C-30 and OES-18.<br><br /><br /><br>Questionnaires preoperatively and at 3, 6, 9 and 12 months after surgery.