Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

March 17, 2024 updated by: Qilu Hospital of Shandong University

Evaluation of Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy: a Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Polyethylene Glycol Electrolytes Powder (II)
Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation.
Other Names:
  • laxatives for bowel preparation
Experimental: Low residue diet arm
Low residue diet 1 day before the test, fasting from 20:00 pm.
Other: Low residue diet
Low residue diet 1 day before the test, fasting from 20:00 pm.
Experimental: Normal diet arm
Normal diet 1 day before the test, fasting from 20:00 pm.
Other: Normal diet
Normal diet 1 day before the test, fasting from 20:00 pm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality of small intestine
Time Frame: 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.
1 day (Upon completion of the examination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of completion of inspections
Time Frame: 1 day (Upon completion of the examination)
The examination is considered complete when the capsule reaches the cecum.
1 day (Upon completion of the examination)
Small intestine transit time
Time Frame: 1 day (Upon completion of the examination)
Time taken for the capsule to pass through the entire small intestine to reach the cecum.
1 day (Upon completion of the examination)
Lesion detection rate
Time Frame: 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.
1 day (Upon completion of the examination)
Patient tolerance
Time Frame: 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.
1 day (Upon completion of the examination)
Rate of adverse events
Time Frame: 1 day (Upon completion of the examination)
Patients were observed for adverse events (nausea, vomiting, bloating, etc.) and for capsule retention after examination.
1 day (Upon completion of the examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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