Repetitive Position Change Improves Gastric Cleanliness for MCE

Stomach Diseases Clinical Trial

Official title:

Repetitive Position Change After Dimethicone Premedication Improves Gastric Cleanliness for Magnetically Controlled Capsule Endoscopy: a Single-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514966
• Other study ID #: MCE-RPC
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: June 14, 2018

Study information

• Verified date: July 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 14, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

• Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;

• Currently participating in another clinical study.

Related Conditions & MeSH terms

• Stomach Diseases

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	30 minutes
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.	30 minutes
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.	2 weeks