Gastric Transit Time, Small-bowel Transit Time
Conditions
Brief summary
The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.
Detailed description
The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).
Interventions
OTHERChewing Gum
Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.
OTHERControl
The control group will not chew chewing gum while undergoing capsule endoscopy
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The patients were instructed not to tell the endoscopist or the investigators about whether or not they used chewing gum before, during, or after the SBCE procedure.
Intervention model description
Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 years and \<80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.
Exclusion criteria
* Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure. * Patients, who have proven or suspected obstruction of the bowel. * Patients, who have had prior small bowel and/or gastric surgery. * Patients, who have a dysphagia prohibiting. * Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gastric transit time | 1 hour | the time interval between the first gastric image and the first duodenal image |
| small bowel transit time | 8 hour | The time interval between the first duodenal images and the first caecal image |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate | 9 hours | the capsule reaching the caecum |
| Diagnostic yield | 9 hours | the total number of positive (diagnostic and suspicious) findings |
| Intervention rate | 1 hours | Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour |
Countries
China
Outcome results
None listed