NCT05606822|Recruiting
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Sponsor study identifier
observational
200
1 country
1
Study Start
October 1, 2021
Actual (reported)Primary Completion
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2021
Actual (reported)October 26, 2022
Actual (reported)November 7, 2022
Actual (reported)October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Success rate
Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy
1-3 years
Mortality
6 months (due to possible prolonged hospital stay)
Adverse events
6 months
Treatment cycles
6 months
No interventions will be administered, as this is an observational study.
No interventions will be administered, as this is an observational study.
Collection of data from electronic health record
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.
Amsterdam University Medical Centers, location VUmc
Amsterdam, Netherlands
Pattynama LMD, Pouw RE, Henegouwen MIVB, Daams F, Gisbertz SS, Bergman JJGHM, Eshuis WJ. Endoscopic vacuum therapy for anastomotic leakage after upper gastrointestinal surgery. Endoscopy. 2023 Nov;55(11):1019-1025. doi: 10.1055/a-2102-1691. Epub 2023 May 30.
Luttikhold J, Pattynama LMD, Seewald S, Groth S, Morell BK, Gutschow CA, Ida S, Nilsson M, Eshuis WJ, Pouw RE. Endoscopic vacuum therapy for esophageal perforation: a multicenter retrospective cohort study. Endoscopy. 2023 Sep;55(9):859-864. doi: 10.1055/a-2042-6707. Epub 2023 Feb 24.
Roos Pouw, MD, PhD
Amsterdam University Medical Center, location VU
First Submitted
October 26, 2022
First Posted
November 7, 2022
Study Start
October 1, 2021
Actual (reported)Primary Completion
October 1, 2030
EstimatedEpidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes
Duration of treatment
6 months
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 23, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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