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Vasa brevia

Ligation of the gastrosplenic ligament during upper gastrointestinal surgery; Effect on splenic and gastric perfusion: pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28998
Enrollment
10
Registered
2018-06-12
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux, surgery, antireflux, fundoplication, icg

Interventions

The main endpoint of this study is the observation of a perfusion defect in the spleen and/or gastric fundus. This endpoint will be measured by visual inspection of the blood flow of the spleen and ga

Sponsors

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age =18 - Objectively proven GERD (by gastroscopy, manometry, 24-hour pH and/or impedance monitoring) - Written informed consent for study participation

Exclusion criteria

Exclusion criteria: - Age <18 - Pregnancy - Breastfeeding - Achalasia - Previous gastric surgery - Previous esophageal surgery - Inability to understand the Dutch language - Inability to understand and/or fill in the informed consent form - Adverse reactions to indocyanine green, sodium iodide or iodide - Hyperthyroidism, thyroid adenoma - Liver insufficiency - Reduced kidney function as defined by a Glomerular Filtration Rate of < 40

Design outcomes

Primary

MeasureTime frame
The main endpoint of this study is the observation of a perfusion defect in the spleen and/or gastric fundus. Possible observations are no perfusion defect, possible perfusion defect and definite perfusion defect in one or both organs.

Secondary

MeasureTime frame
The quality of the assessment of perfusion will be scored as adequate or inadequate.

Contacts

Public ContactWA Draaisma

-

w.draaisma@jbz.nl(073) 553 20 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)