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

Completed

Conditions: Acid reflux
Reflux
10017998

Registration Number: NL-OMON45909

Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Age *18
- Objectively proven GERD (ie. by gastroscopy, manometry, 24-hour pH and/or impedance monitoring)
- Written informed consent for study participation

Exclusion Criteria

- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is the observation of a perfusion defect in the<br /><br>spleen and/or gastric fundus.<br /><br><br /><br>This endpoint will be measured by visual inspection of the blood flow of the<br /><br>spleen and gastric fundus during surgery, as made possible by the indocyanine<br /><br>green. As a control measurement, a visual assessment will be performed both<br /><br>before and after ligation of the gastrosplenic ligament. More information on<br /><br>this assessment will be provided in chapter 8.3. Independent observations of<br /><br>the surgeon, assistant and researcher will be recorded.<br /><br><br /><br>Possible observations are no perfusion defect, possible perfusion defect and<br /><br>definite perfusion defect in one or both organs.</p><br>

Secondary Outcome Measures