Fibrin Sealant in Esophageal Surgery
Not Applicable
Completed
- Conditions
- Anastomotic Leak
- Interventions
- Device: Autologous activated fibrin sealant
- Registration Number
- NCT03251040
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Aged 18 - 90 years
- Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy).
- physical status (American Society of Anesthesiologists) of 3 or lower
Exclusion Criteria
- Other malignancies
- Previous esophageal surgery were excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fibrin sealant Autologous activated fibrin sealant Single arm pilot study
- Primary Outcome Measures
Name Time Method Anastomotic leakage 30-day morbidity
- Secondary Outcome Measures
Name Time Method