Stomach Diseases
Conditions
Keywords
Position change, Gastric cleanliness, Magnetically controlled capsule endoscopy
Brief summary
By comparing dimethicone administration with/without subsequent repetitive position change before magnetically controlled capsule endoscopy (MCE) examination, the investigators aim to determine the efficacy of repetitive position change in improving gastric cleanliness for MCE examination.
Detailed description
This is a single-blind, randomized controlled trial. Subjects receiving magnetically controlled capsule endoscopy at the institution will be randomly allocated into positional change group and conventional group before the procedure. 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, and undergo MCE examination. Gastric cleanliness will be rated by two physicians independently.
Interventions
BEHAVIORALPosition change group
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.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients aged more than 18 years, who were scheduled to undergo a magnetically controlled capsule endoscopy, were eligible for this study.
Exclusion criteria
* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation; * Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves; * Pregnancy or suspected pregnancy; *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Cleanliness of Gastric Cavity | 30 minutes | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy | 30 minutes | Positive findings defined as any pathology detected by Magnetically controlled capsule gastroscopy (MCCG), including polyps, ulcer, gastric fundus varices, submucosal tumor, and carditis. |
| Number of Participants With Adverse Events | 2 weeks | Safety 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. |
Countries
China
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Position Change Group 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. | 43 |
| Total | 83 |
Baseline characteristics
| Characteristic | Conventional Group | Position Change Group | Total |
|---|---|---|---|
| Age, Continuous | 45.3 years | 49.6 years | 47.5 years |
| BMI | 24.6 kg/m^2 STANDARD_DEVIATION 3.7 | 22.9 kg/m^2 STANDARD_DEVIATION 3.1 | 23.9 kg/m^2 STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 40 participants | 43 participants | 93 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 30 Participants |
| Sex: Female, Male Male | 30 Participants | 23 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 43 |
| other Total, other adverse events | 0 / 40 | 0 / 43 |
| serious Total, serious adverse events | 0 / 40 | 0 / 43 |
Outcome results
Primary
Image Cleanliness of Gastric Cavity
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)
Time frame: 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Group | Image Cleanliness of Gastric Cavity | cardia | 3.0 units on a scale | Standard Deviation 0.6 |
| Conventional Group | Image Cleanliness of Gastric Cavity | fundus | 2.2 units on a scale | Standard Deviation 0.7 |
| Conventional Group | Image Cleanliness of Gastric Cavity | body | 2.7 units on a scale | Standard Deviation 0.7 |
| Conventional Group | Image Cleanliness of Gastric Cavity | angulus | 3.1 units on a scale | Standard Deviation 0.7 |
| Conventional Group | Image Cleanliness of Gastric Cavity | antrum | 3.7 units on a scale | Standard Deviation 0.5 |
| Conventional Group | Image Cleanliness of Gastric Cavity | pylorus | 3.9 units on a scale | Standard Deviation 0.3 |
| Position Change Group | Image Cleanliness of Gastric Cavity | antrum | 4.0 units on a scale | Standard Deviation 0 |
| Position Change Group | Image Cleanliness of Gastric Cavity | cardia | 3.5 units on a scale | Standard Deviation 0.5 |
| Position Change Group | Image Cleanliness of Gastric Cavity | angulus | 3.7 units on a scale | Standard Deviation 0.5 |
| Position Change Group | Image Cleanliness of Gastric Cavity | fundus | 3.0 units on a scale | Standard Deviation 0.6 |
| Position Change Group | Image Cleanliness of Gastric Cavity | pylorus | 4.0 units on a scale | Standard Deviation 0 |
| Position Change Group | Image Cleanliness of Gastric Cavity | body | 3.1 units on a scale | Standard Deviation 0.4 |
Secondary
Number of Participants With Adverse Events
Safety 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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | Number of Participants With Adverse Events | 0 participants |
| Position Change Group | Number of Participants With Adverse Events | 0 participants |
Secondary
The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy
Positive findings defined as any pathology detected by Magnetically controlled capsule gastroscopy (MCCG), including polyps, ulcer, gastric fundus varices, submucosal tumor, and carditis.
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Group | The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy | 11 findings |
| Position Change Group | The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy | 12 findings |