Objective: to determine the feasibility of planned eating and drinking in preparation for oeshophagus-gastroduodenoscopy.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary feasibility outcomes are reach and recruitment, dose received, fidelity
and limited efficacy. Reach and recruitment will be measured with inclusion
rate and barriers to participate. Dose will be measured as patients
satisfaction and barriers for adherence. Fidelity will be measured with
adequate fasting time. Limited efficacy will be estimated with gastric
visibility and comfort.
Secondary outcome
Secondary effectiveness outcomes are time of procedures, and complications.
Background summary
Background: Fasting before oesophago-gastro-duodenoscopy (OGD) is necessary for
a clear view on the mucosa. Prolonged fasting periods leads to discomfort in
patients with symptoms as thirst, hunger, anxiety, and stress. Preprocedural
glucose loading leads to less preoperative discomfort.
Study objective
Objective: to determine the feasibility of planned eating and drinking in
preparation for oeshophagus-gastroduodenoscopy.
Study design
Design: a non-controlled pilot study.
Intervention
Intervention: Patients will be instructed to eat until six and drink until two
hours in preparation of the gastroscopy. patients can choose to consume
standardized products. The standardized meal contained 357 kcal of energy, 15.7
gram protein, and 8.8 gram fats and is to be consumed at least 6,5 hours before
the gastroscopy. The standardized drinks had a volume of 150ml and contained
58kcal of energy and was to be consumed at 2 hours before the gastroscopy.
Study burden and risks
Ethics: Patients are requested to provide informed consent before
participation. Data collection with questionnaires will take approximately 15
minutes. Eating and drinking will benefit their comfort in preparation of the
scopy, however, strict adherence to the instructions may result in eating
during the night.
Willy Brandtlaan 10
Ede 6717ZP
NL
Willy Brandtlaan 10
Ede 6717ZP
NL
Listed location countries
Age
Inclusion criteria
patients who are planned for gastroduodenoscopy at outpatient clinic basis;
• if they were 18 years old and beyond,
• if they were able to consume foods per mouth
• provided informed consent.
Exclusion criteria
• patients who have had bariatric surgery
• patients with had a clinical proven gastropareses or absence of swallow reflex
• patients with diabetes mellitus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73331.081.20 |