Fibrin Sealant in Esophageal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Anastomotic Leak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fibrin sealant

Single arm pilot study

Group Type OTHER

Autologous activated fibrin sealant

Intervention Type DEVICE

Application of fibrin sealant

Interventions

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Autologous activated fibrin sealant

Application of fibrin sealant

Intervention Type DEVICE

Eligibility Criteria

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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