Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

Not Applicable

Recruiting

• Conditions: Magnetically Controlled Capsule Endoscopy; Bowel Preparation
• Interventions: Other: Normal diet; Drug: Polyethylene Glycol Electrolytes Powder (II); Other: Low residue diet

• Registration Number: NCT06313242
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study Start: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-15
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal diet arm	Normal diet	Normal diet 1 day before the test, fasting from 20:00 pm.
Laxatives arm	Polyethylene Glycol Electrolytes Powder (II)	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.
Low residue diet arm	Low residue diet	Low residue diet 1 day before the test, fasting from 20:00 pm.

Primary Outcome Measures

Name	Time	Method
Image quality of small intestine	1 day (Upon completion of the examination)	The small bowel cleanliness score and the small bowel bubble volume score were used to evaluate image quality.

Secondary Outcome Measures

Name	Time	Method
Small intestine transit time	1 day (Upon completion of the examination)	Time taken for the capsule to pass through the entire small intestine to reach the cecum.
Patient tolerance	1 day (Upon completion of the examination)	Evaluated by completing a case report form based on the patient's personal feelings during the bowel preparation process.
Rate of completion of inspections	1 day (Upon completion of the examination)	The examination is considered complete when the capsule reaches the cecum.
Rate of adverse events	1 day (Upon completion of the examination)	Patients were observed for adverse events (nausea, vomiting, bloating, etc.) and for capsule retention after examination.
Lesion detection rate	1 day (Upon completion of the examination)	Proportion of cases with lesions relevant to the indication for examination or capable of explaining the patient's complaints or symptoms to the total number of cases.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, China