Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

Shandong University

Status: Enrolling

Conditions: Magnetically Controlled Capsule Endoscopy; Bowel Preparation

Treatments: Drug: Polyethylene Glycol Electrolytes Powder (II); Other: Low residue diet; Other: Normal diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06313242

202403

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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375 participants in 3 patient groups

Laxatives arm

Active Comparator group

Description:

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.

Treatment:

Drug: Polyethylene Glycol Electrolytes Powder (II)

Low residue diet arm

Experimental group

Description:

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

Treatment:

Other: Low residue diet

Normal diet arm

Experimental group

Description:

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

Treatment:

Other: Normal diet