Trial Outcomes & Findings for Repetitive Position Change Improves Gastric Cleanliness for MCE (NCT NCT03514966)
NCT ID: NCT03514966
Last Updated: 2019-07-09
Results Overview
The image cleanliness of gastric cavity of six primary anatomical landmarks of stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but does not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1)
COMPLETED
NA
83 participants
30 minutes
2019-07-09
Participant Flow
Patients with the following were excluded: (1) dysphagia or symptoms of gastric outlet obstruction; (2) poor general condition; (3) a pacemaker or other implanted electromedical devices, or artificial heart valves; (4) pregnancy or suspected pregnancy; (5) exclusion criteria for standard magnetic resonance imaging examination
Participant milestones
| Measure |
Conventional Group
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
|
Position Change Group
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group were instructed by the study nurses to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine position, left lateral position, three cycles of prone, left lateral, supine, and right lateral positions, and finally supine position, with a duration of 1 min for each position. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
|
Overall Study
COMPLETED
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Conventional Group
n=40 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
|
Position Change Group
n=43 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
n=40 Participants
|
49.6 years
n=43 Participants
|
47.5 years
n=83 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=40 Participants
|
20 Participants
n=43 Participants
|
30 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=40 Participants
|
23 Participants
n=43 Participants
|
53 Participants
n=83 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
40 participants
n=40 Participants
|
43 participants
n=43 Participants
|
93 participants
n=83 Participants
|
|
BMI
|
24.6 kg/m^2
STANDARD_DEVIATION 3.7 • n=40 Participants
|
22.9 kg/m^2
STANDARD_DEVIATION 3.1 • n=43 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=83 Participants
|
PRIMARY outcome
Timeframe: 30 minutesThe image cleanliness of gastric cavity of six primary anatomical landmarks of stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but does not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1)
Outcome measures
| Measure |
Conventional Group
n=40 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
|
Position Change Group
n=43 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
|
|---|---|---|
|
Image Cleanliness of Gastric Cavity
antrum
|
3.7 units on a scale
Standard Deviation 0.5
|
4.0 units on a scale
Standard Deviation 0.0
|
|
Image Cleanliness of Gastric Cavity
cardia
|
3.0 units on a scale
Standard Deviation 0.6
|
3.5 units on a scale
Standard Deviation 0.5
|
|
Image Cleanliness of Gastric Cavity
fundus
|
2.2 units on a scale
Standard Deviation 0.7
|
3.0 units on a scale
Standard Deviation 0.6
|
|
Image Cleanliness of Gastric Cavity
body
|
2.7 units on a scale
Standard Deviation 0.7
|
3.1 units on a scale
Standard Deviation 0.4
|
|
Image Cleanliness of Gastric Cavity
angulus
|
3.1 units on a scale
Standard Deviation 0.7
|
3.7 units on a scale
Standard Deviation 0.5
|
|
Image Cleanliness of Gastric Cavity
pylorus
|
3.9 units on a scale
Standard Deviation 0.3
|
4.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 30 minutesPositive findings defined as any pathology detected by Magnetically controlled capsule gastroscopy (MCCG), including polyps, ulcer, gastric fundus varices, submucosal tumor, and carditis.
Outcome measures
| Measure |
Conventional Group
n=40 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
|
Position Change Group
n=43 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
|
|---|---|---|
|
The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy
|
11 findings
|
12 findings
|
SECONDARY outcome
Timeframe: 2 weeksSafety of MCCG, or adverse events, defined as symptoms or signs such as abdominal distention, nausea, or vomiting, were monitored closely during the MCCG procedure. Capsule retention (i.e., a capsule endoscope remaining in the gastrointestinal tract for more than two weeks or a capsule endoscope that requires directed intervention or therapy to aid its expulsion) was monitored and followed up for up to two weeks.
Outcome measures
| Measure |
Conventional Group
n=40 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCE examination.
|
Position Change Group
n=43 Participants
Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 participants
|
0 participants
|
Adverse Events
Conventional Group
Position Change Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place