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Repetitive Position Change Improves Gastric Cleanliness for MCE

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ClinicalTrials.gov Identifier: NCT03514966
Recruitment Status : Completed
First Posted : May 3, 2018
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Stomach Diseases
Intervention Behavioral: Position change group
Enrollment 83
Recruitment Details  
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
Arm/Group Title Conventional Group Position Change Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 40 43
Completed 40 43
Not Completed 0 0
Arm/Group Title Conventional Group Position Change Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 40 43 83
Hide Baseline Analysis Population Description
Subjects who met the inclusion criteria will be randomly allocated into position change or conventional groups. An independent research assistant generated the computerized random number sequence.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 43 participants 83 participants
45.3
(20 to 69)
49.6
(22 to 80)
47.5
(20 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 83 participants
Female
10
  25.0%
20
  46.5%
30
  36.1%
Male
30
  75.0%
23
  53.5%
53
  63.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 40 participants 43 participants 83 participants
40 43 93
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 43 participants 83 participants
24.6  (3.7) 22.9  (3.1) 23.9  (3.5)
1.Primary Outcome
Title Image Cleanliness of Gastric Cavity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Group Position Change Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 40 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
cardia 3.0  (0.6) 3.5  (0.5)
fundus 2.2  (0.7) 3.0  (0.6)
body 2.7  (0.7) 3.1  (0.4)
angulus 3.1  (0.7) 3.7  (0.5)
antrum 3.7  (0.5) 4.0  (0.0)
pylorus 3.9  (0.3) 4.0  (0.0)
2.Secondary Outcome
Title The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Group Position Change Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 40 43
Measure Type: Number
Unit of Measure: findings
11 12
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Group Position Change Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 40 43
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame 2 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Conventional Group Position Change Group
Hide Arm/Group Description 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 MCCG examination. 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 MCCG examination.
All-Cause Mortality
Conventional Group Position Change Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Group Position Change Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Group Position Change Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/43 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Changhai Hospital
Organization: Department of Gastroenterology
Phone: 86-21-31161004 ext 86-21-6549
EMail: liaozhuan@smmu.edu.cn
Layout table for additonal information
Responsible Party: Zhuan Liao, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03514966     History of Changes
Other Study ID Numbers: MCE-RPC
First Submitted: April 17, 2018
First Posted: May 3, 2018
Results First Submitted: January 7, 2019
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019