Fibrin Sealant in Esophageal Surgery (SEAL)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Anastomotic Leak

Treatments: Device: Autologous activated fibrin sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT03251040

2015.458

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Fibrin sealant

Other group

Description:

Single arm pilot study

Treatment:

Device: Autologous activated fibrin sealant