Capsule EndoscopyNCT04970277
Efficacy of Drinking Water During Capsule Endoscopy
A study testing drinking water group in people with Capsule Endoscopy, run by Shandong University at 1 site in China.
Trial summary
The aims of this study are to evaluate the effect of early drinking water after the capsule ingestion on the gastrointestinal transit and image quality of capsule endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsule Endoscopy
- What is being tested?
- drinking water group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years undergoing capsule endoscopy
Who cannot join
- Patients with suspected intestinal obstruction, intestinal diverticulum, stricture or fistula
- previous gastric or small-bowel surgery
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, MD, PhD, 86 15588818685 ext. 0531-88369277, zuoxiuli@sdu.edu.cn
About this study
Official title: Efficacy of Drinking Water on Transit Time and Complete Examination Rate During Capsule Endoscopy
The aims of this study are to evaluate the effect of early drinking water after the capsule ingestion on the gastrointestinal transit and image quality of capsule endoscopy.
Read the detailed description
Capsule endoscopy has been a significant technologic advancement that has allowed the direct examination of mucosa throughout the entire small intestine in a noninvasive fashion; and it has become the primary technique for imaging the small bowel. However, as imaging time is limited to about 8 hours, a prolonged transit of the capsule endoscope in the stomach may result in an incomplete small bowel transit (i.e. failure of the capsule to reach the cecum). Delayed transit time of stomach may be responsible for the failure of capsule endoscopy to visualize the distal portions of the small bowel, and potentially may result in the inability to identify small-bowel pathology in these areas. Previous study showed that drinking water might improve completion rate of capsule endoscopy. And bowel preparation of clear liquids may improve image quality of small bowel mucosa. The aim of this study was to assess the effect of drinking water on the transit time，completion rate and image quality of capsule endoscopy.
- Conditions
- Capsule Endoscopy
- Being tested
- drinking water group, control group
- Keywords
- Capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drinking water groupOther
Those randomized to drink water group were asked to drink 200 mL colorless water every 10 minutes, starting at the time of capsule ingestion until three times in total.
control groupOther
Those randomized to control group were asked not to drink extra water after capsule ingestion.
| Study group | Role | What they receive |
|---|---|---|
| drinking water group | Experimental | Patients in this group drink colorless water after capsule ingestion. Receives: Other: drinking water group |
| control group | Other | Patients in this group don't drink colorless water after capsule ingestion. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric transit time
the time between the first gastric image and the first duodenal image
Measured: 3 months
small-bowel transit time
the imaging time of capsule endoscopy in the small bowel
Measured: 3 months
Secondary outcomes (3)
complete examination rate of the small bowel
the percentage of patients with complete examination of the small bowel in each group
Measured: 3 months
image quality
The scale was based on the uncovered image area percentage (0, 0%-20%; 1, 20%-40%; 3, 60%-80%; 4, 80%-100%). The image quality was based on the mean of 5-min scores and higher scores mean a better outcome.
Measured: 3 months
diagnostic yields
Clinical diagnoses made by the capsule endoscopy were recorded for each patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start18 Jul 2021
- Primary completion6 Apr 2022
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsule EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD, PhD, Principal investigator, Shandong University Qilu hosipital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970277
- Sponsor's protocol ID
- 2021SDU-QILU-054
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2021
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Drinking Water on Transit Time and Complete Examination Rate During Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT04970277
- Acronym / sponsor ID
- 2021SDU-QILU-054
- Conditions
- Capsule Endoscopy
- Keywords
- Capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- May 2022 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are to evaluate the effect of early drinking water after the capsule ingestion on the gastrointestinal transit and image quality of capsule endoscopy.
Detailed description
Capsule endoscopy has been a significant technologic advancement that has allowed the direct examination of mucosa throughout the entire small intestine in a noninvasive fashion; and it has become the primary technique for imaging the small bowel. However, as imaging time is limited to about 8 hours, a prolonged transit of the capsule endoscope in the stomach may result in an incomplete small bowel transit (i.e. failure of the capsule to reach the cecum). Delayed transit time of stomach may be responsible for the failure of capsule endoscopy to visualize the distal portions of the small bowel, and potentially may result in the inability to identify small-bowel pathology in these areas. Previous study showed that drinking water might improve completion rate of capsule endoscopy. And bowel preparation of clear liquids may improve image quality of small bowel mucosa. The aim of this study was to assess the effect of drinking water on the transit time，completion rate and image quality of capsule endoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drinking water group | Experimental | Other: drinking water groupPatients in this group drink colorless water after capsule ingestion. |
| control group | Other | Other: control groupPatients in this group don't drink colorless water after capsule ingestion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-80 years undergoing capsule endoscopy
Key exclusion criteria (3 listed)
- Patients with suspected intestinal obstruction, intestinal diverticulum, stricture or fistula
- previous gastric or small-bowel surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drinking water groupThose randomized to drink water group were asked to drink 200 mL colorless water every 10 minutes, starting at the time of capsule ingestion until three times in total. | Other | drinking water group |
| control groupThose randomized to control group were asked not to drink extra water after capsule ingestion. | Other | control group |
Primary outcome
gastric transit time
Time frame: 3 months
the time between the first gastric image and the first duodenal image
small-bowel transit time
Time frame: 3 months
the imaging time of capsule endoscopy in the small bowel
3 secondary outcomes
complete examination rate of the small bowel
Time frame: 3 months
image quality
Time frame: 3 months
diagnostic yields
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zuo, MD, PhD principal investigator
Shandong University Qilu hosipital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drinking water group in people with Capsule Endoscopy, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo, MD, PhD (86 15588818685 ext. 0531-88369277, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric transit time (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.