The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy
Condition: Gastric Disease; Capsule Endoscopy
MeSH terms: Stomach Diseases
Study type: Interventional

Summary: 
      Magnetically controlled capsule endoscopy (MCE) is a noninvasive technique (90.4%
      sensitivity, 94.7% specificity and 93.4% accuracy) without requiring sedation or air
      insufflation, which makes it welcomed by most of participants. However, due to the large size
      of the stomach, clear views are obtained with the stomach distended. Participants were asked
      to drink 1000ml water for gastric preparation in a short time according to the standard
      procesure. It is hard for some participants especially the old and can cause discomfort. If
      the capsule stays in the stomach for a long time (>4 hours), it will affect the completion
      rate of small intestine examination and be inconvient to both of the endoscopist and patient.

      It is a promising way to fill the stomach with carbonated drinks in some diagnosis and
      treatment methods. A study using carbonated drinks for gastric filling in the procedure of
      multi slice spiral computed tomography (MSCT) showed higher diagnostic rate for gastric
      cancer (85%VS80%). Rapid filling and absorption, greater comfort feeling and little pressure
      changes lead to higher acceptance of participants.

      So, researchers have a novel idea using soda water to take place of pure water in the gastric
      preparation. The combination of gas and liquid in gastric filling greatly reduces the amount
      of fluid that participants need to drink, which makes the shorter preparation time and less
      feeling of fullness. In a pilot study before, investigators found the usage of soda water
      obtained similar gastric distention score and shorter gastric transit time (GTT) than
      standard preparation method.

      This prospective, single blind, randomized controlleds trial aimed to prove the safety and
      efficiency of soda water in the process of gastric preparation and explore the impact on the
      follow-up small bowel examination.
    

Detailed description: 
      This is a prospective, single blind, randomized controlled clinical study approved by the
      Endoscopy Center of Changhai Hospital in Shanghai from July, 2020 to September,2020. Approval
      to carry out this study was granted by the Ethics Committee, Changhai Hospital, Naval Medical
      University.

      According to the results of our pilot study, 252 participants(with 20% withdrawal rate) aged
      18-75 will accept standard gastric preparation or gastric preparation with soda water
      randomly (ratio 1:1).All patient will provid written informed consent for this study before
      undergoing baseline MCE.

      Investigators evaluated the feasibility of a novel gastric preparation methods regimens on
      gastric distention,gastric cleansing, feeling of fullness, diagnostic yield, satisfaction
      questionnaire, gastric transit time, small bowel transit time and completion rate. The safety
      were evaluated at two week after procedure for the occurance of adverse events. Investigators
      also plan to explore whether soda water can affect the subsequent examination of the small
      intestine, and the difficulty in intervention under special circumstances.

      All participants underwent a bowel preparation that consisted of a low-residue diet for 24
      hours, fluid intake, and ingestion of 2L polyethylene glycol-based electrolyte solution 12
      hours before the examination. On the examination day, participants arrived at hospital in the
      morning after an over night fast (>8hours). Then they would be randomly assigned to controll
      group or soda group.

      Control group:40 minutes before capsule ingestion, all participants swallowed 100ml clear
      water containing 50mg simethicone. During the period, participants were asked to have a
      proper walk to wash out bubbles. An additional 900ml clear water was drunk to obtain good
      vision before undergoing MCE examination.

      Soda water group：Control group:40 minutes before capsule ingestion, all participants
      swallowed 100ml clear water containing 50mg simethicone. During the period, participants were
      asked to have a proper walk to wash out bubbles. An additional 400ml soda water was drunk to
      obtain good vision before undergoing MCE examination.

      Then, the patient enter the examination room to finish the examination.
    

Intervention name(s): Soda-water instead of pure water to observe gastric filling
Intervention type(s): Procedure
Intervention description(s): All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of 2L polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at hospital in the morning after an over night fast (>8hours). Then they would be randomly assigned to controll group or soda group. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg simethicone. During the period, patients were asked to have a proper walk to wash out bubbles. An additional 900ml pure water or 400ml soda-water was drunk to obtain good vision before undergoing MCE examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: capsule endoscopy; gastric distention; gastric transit time; clinical trial