Tritional Route In Esophageal resectioN Trial II
Completed
- Conditions
- esophagectomy10017990
- Registration Number
- NL-OMON42802
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 148
Inclusion Criteria
• Patients that undergo a minimally invasive/hybrid esophagectomy with intrathoracic anastomosis for cancer.
• written informed consent
• age >18 years
Exclusion Criteria
• Inability for oral intake
• Inability to place a surgical feeding jejunostomy
• Inability to provide written consent or inability to fill out questionnaires
• Swallowing disorder
• Achalasia
• Malnutrition (defined as >15% weight loss just before start of the surgery)
• Karnofsky Performance Status < 80
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Functional recovery</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Pulmonary complications (Pneumonia, Acute respiratory distress syndrome<br /><br>(ARDS), respiratory insufficiency requiring treatment)<br /><br>- Anastomotic leakage (clinically and amylase levels in drain fluid)<br /><br>- Nutritional status (weight loss, sarcopenia, intake)<br /><br>- Need for parenteral feeding/ placement of a nasojejunal feeding tube<br /><br>- Need for additional surgical, radiological or endoscopic interventions<br /><br>- 30-day surgical complications (classified according to Clavien-Dindo)<br /><br>- Other complications requiring treatment (i.e. urinary tract infection)<br /><br>- Need for ICU admission and total length of ICU stay<br /><br>- Quality of life</p><br>