Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313242
• Other study ID #: 202403
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Qilu Hospital of Shandong University
• Contact: Feixue Chen, Ph.D
• Phone: 18560086108
• Email: chenfeixue[@]email.sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

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

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Gkolfakis P, Tziatzios G, Dimitriadis GD, Triantafyllou K. Meta-analysis of randomized controlled trials challenging the usefulness of purgative preparation before small-bowel video capsule endoscopy. Endoscopy. 2018 Jul;50(7):671-683. doi: 10.1055/s-0043-125207. Epub 2018 Feb 6. — View Citation

Gomez-Reyes E, Tepox-Padron A, Cano-Manrique G, Vilchis-Valadez NJ, Mora-Bulnes S, Medrano-Duarte G, Chaires-Garza LG, Grajales-Figueroa G, Ruiz-Romero D, Tellez-Avila FI. A low-residue diet before colonoscopy tends to improve tolerability by patients with no differences in preparation quality: a randomized trial. Surg Endosc. 2020 Jul;34(7):3037-3042. doi: 10.1007/s00464-019-07100-6. Epub 2019 Sep 3. — View Citation

Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6. — View Citation

Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11. — View Citation

Kong QZ, Peng C, Li Z, Tian BL, Li YY, Chen FX, Zuo XL, Li YQ. Inadequate gastric preparation and its associated factors for magnetically controlled capsule endoscopy. Front Pharmacol. 2023 Aug 28;14:1184754. doi: 10.3389/fphar.2023.1184754. eCollection 2023. — View Citation

Nguyen DL, Jamal MM, Nguyen ET, Puli SR, Bechtold ML. Low-residue versus clear liquid diet before colonoscopy: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. 2016 Mar;83(3):499-507.e1. doi: 10.1016/j.gie.2015.09.045. Epub 2015 Oct 13. — View Citation

Reumkens A, van der Zander Q, Winkens B, Bogie R, Bakker CM, Sanduleanu S, Masclee AAM. Electrolyte disturbances after bowel preparation for colonoscopy: Systematic review and meta-analysis. Dig Endosc. 2022 Jul;34(5):913-926. doi: 10.1111/den.14237. Epub 2022 Feb 23. — View Citation

Wu TT, Zhang MY, Tan ND, Chen SF, Zhuang QJ, Luo Y, Xiao YL. Patients at risk for further examination with conventional gastroscopy after undergoing magnetically controlled capsule endoscopy. J Dig Dis. 2023 Oct;24(10):522-529. doi: 10.1111/1751-2980.13228. Epub 2023 Oct 3. — View Citation

Outcome

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