Fibrin Sealant in Esophageal Surgery (SEAL)

A

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)

15 participants in 1 patient group

Fibrin sealant
Other group
Description:
Single arm pilot study
Treatment:
Device: Autologous activated fibrin sealant

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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