An interventional study of Autologous activated fibrin sealant in Anastomotic Leak, sponsored by Amsterdam UMC, location VUmc. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Prevention
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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.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's enrollment of 15 is below the median of 140 across 128 interventional studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm pilot study
Device: Autologous activated fibrin sealant
Application of fibrin sealant
Anastomotic leakage
Time frame: 30-day morbidity
No study locations are listed for this record.
Plan to share: No
Ran from Aug 2015 to primary completion in Apr 2016, 8 months.
Of 58 non-industry interventional studies with no phase under Anastomotic Leak, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's 8 months is below that.
Counting every sponsor, half of 65 studies reached it within 32 months; a quarter within 19 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Amsterdam UMC, location VUmc →