Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction
1 other identifier
interventional
32
1 country
1
Brief Summary
The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2005
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 7, 2006
CompletedFirst Posted
Study publicly available on registry
June 8, 2006
CompletedJune 8, 2006
June 1, 2006
June 7, 2006
June 7, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
differences in Microvascular bloodflow
differences in microvascular hemoglobinsaturation
Secondary Outcomes (2)
differences in anastomotic leakage
differences in anastomotic stenosis
Interventions
Eligibility Criteria
You may qualify if:
- Planned esophagectomy with gastric tube reconstruction
- written informed consent
- ASA I and II
You may not qualify if:
- younger than 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus MC
Rotterdam, 3000ZA, Netherlands
Related Publications (5)
Buise MP, Ince C, Tilanus HW, Klein J, Gommers D, van Bommel J. The effect of nitroglycerin on microvascular perfusion and oxygenation during gastric tube reconstruction. Anesth Analg. 2005 Apr;100(4):1107-1111. doi: 10.1213/01.ANE.0000147665.60613.CA.
PMID: 15781529BACKGROUNDPierie JP, de Graaf PW, van Vroonhoven TJ, Obertop H. Healing of the cervical esophagogastrostomy. J Am Coll Surg. 1999 Apr;188(4):448-54. doi: 10.1016/s1072-7515(99)00003-4. No abstract available.
PMID: 10195730BACKGROUNDJacobi CA, Zieren HU, Zieren J, Muller JM. Is tissue oxygen tension during esophagectomy a predictor of esophagogastric anastomotic healing? J Surg Res. 1998 Feb 1;74(2):161-4. doi: 10.1006/jsre.1997.5239.
PMID: 9587355BACKGROUNDSiegemund M, van Bommel J, Ince C. Assessment of regional tissue oxygenation. Intensive Care Med. 1999 Oct;25(10):1044-60. doi: 10.1007/s001340051011. No abstract available.
PMID: 10551958BACKGROUNDBuise M, van Bommel J, Jahn A, Tran K, Tilanus H, Gommers D. Intravenous nitroglycerin does not preserve gastric microcirculation during gastric tube reconstruction: a randomized controlled trial. Crit Care. 2006;10(5):R131. doi: 10.1186/cc5043.
PMID: 16970804DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Diederik Gommers, MD, PhD
Erasmus Medical Center
- PRINCIPAL INVESTIGATOR
Marc Buise, MD
Erasmus Medical Center
- STUDY DIRECTOR
Jasper van Bommel, MD, PhD
Erasmus Medical Center
- PRINCIPAL INVESTIGATOR
Huug Tilanus, MD, PhD
Erasmus Medical Center
- PRINCIPAL INVESTIGATOR
Khe Tran, MD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 7, 2006
First Posted
June 8, 2006
Study Start
May 1, 2005
Study Completion
December 1, 2005
Last Updated
June 8, 2006
Record last verified: 2006-06