No registrations found.
ID
Source
Brief title
Health condition
Reflux, surgery, antireflux, fundoplication, icg
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The quality of the assessment of perfusion will be scored as adequate or inadequate.
Background summary
-
Study objective
This pilot study aims to report on the diagnostic value of indocyanine green and fluorescence laparoscopy on vascularization defects of the stomach and spleen during antireflux surgery. It is our hypothesis that many splenic and gastric infarctions occur without the surgeon noticing, and there may be a connection between postoperative pain and this infarction.
Study design
Visual inspection of fluorescence intensity as representation of perfusion, before and directly after ligation of the gastrosplenic ligament.
Intervention
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 gastric fundus during surgery, as made possible by the indocyanine green. As a control measurement, a visual assessment will be performed both before and after ligation of the gastrosplenic ligament. Independent observations of the surgeon, assistant and researcher will be recorded.
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7071 |
| NTR-old | NTR7269 |
| CCMO | NL66435.028.18 |
| OMON | NL-OMON45909 |