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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewing Gum | Active Comparator | The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Subjects chewed one piece of gum for approximately 15 min every 30 min at the first hour of the examination. |
|
| Control | Placebo Comparator | The control group will not chew chewing gum while undergoing capsule endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewing Gum | Other | Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| gastric transit time | the time interval between the first gastric image and the first duodenal image | 1 hour |
| small bowel transit time | The time interval between the first duodenal images and the first caecal image | 8 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate | the capsule reaching the caecum | 9 hours |
| Diagnostic yield | the total number of positive (diagnostic and suspicious) findings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Lv, M.D. | First Affiliated Hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33681244 | Derived | Huang L, Hu Y, Chen F, Liu S, Lu B. Effectiveness of Improved Use of Chewing Gum During Capsule Endoscopy in Decreasing Gastric Transit Time: A Prospective Randomized Controlled Study. Front Med (Lausanne). 2021 Feb 15;8:605393. doi: 10.3389/fmed.2021.605393. eCollection 2021. |
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Individual participant data sharing will be consider after study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2019 | May 7, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
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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.
| Control | Other | The control group will not chew chewing gum while undergoing capsule endoscopy |
|
| 9 hours |
| Intervention rate | Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour | 1 hours |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |