Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2025-06-30

Brief Summary

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The study aimed to compare the effects of bowel preparation methods of a normal diet for 1 day, a low residue diet for 1 day, and laxative bowel cleaning on the image quality of magnetically controlled capsule endoscopy, and to assess the rate of completion of the examination, small intestine transit time, lesion detection, patient tolerance, and safety of the three regimens.

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Detailed Description

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Conditions

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Magnetically Controlled Capsule Endoscopy Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laxatives arm

Normal diet 1 day before the test, fasting and laxatives from 20:00 pm. The laxatives, Polyethylene Glycol Electrolytes Powder (II), should be prepared as a solution and taken as 2000 ml the night before the test and 1000 ml the following morning, within 2 hours and 1 hour, respectively.

Group Type ACTIVE_COMPARATOR

Polyethylene Glycol Electrolytes Powder (II)

Intervention Type DRUG

Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation.

Low residue diet arm

Low residue diet 1 day before the test, fasting from 20:00 pm.

Group Type EXPERIMENTAL

Low residue diet

Intervention Type OTHER

Low residue diet 1 day before the test, fasting from 20:00 pm.

Normal diet arm

Normal diet 1 day before the test, fasting from 20:00 pm.

Group Type EXPERIMENTAL

Normal diet

Intervention Type OTHER

Normal diet 1 day before the test, fasting from 20:00 pm.

Interventions

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Polyethylene Glycol Electrolytes Powder (II)

Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation.

Intervention Type DRUG

Low residue diet

Low residue diet 1 day before the test, fasting from 20:00 pm.

Intervention Type OTHER

Normal diet

Normal diet 1 day before the test, fasting from 20:00 pm.

Intervention Type OTHER

Other Intervention Names

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laxatives for bowel preparation

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years, male or female
2. One of the following examination indications:

(1) Unexplained gastrointestinal bleeding; (2) Unexplained iron deficiency anaemia; (3) Suspected Crohn's disease or monitoring and directing treatment for Crohn's disease; (4) Suspected small bowel tumour; (5) Monitoring the development of small bowel polyposis syndrome; (6) Suspected or difficult to control malabsorption syndromes (e.g., celiac disease, etc.); (7) Detection of NSAID-associated small bowel mucosal damage; (8) Those with a clinical need to exclude small bowel disease.

Exclusion Criteria

1. People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically);
2. Known or suspected gastrointestinal obstruction, stenosis, and fistula;
3. People with implanted cardiac pacemakers or other electronic devices;
4. People with swallowing disorders;
5. Women during pregnancy;
6. People who are unable or unwilling to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No