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Tritional Route In Esophageal resectioN Trial II

Completed
Conditions
esophagectomy
10017990
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
NameTimeMethod
<p>- Functional recovery</p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
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