Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy

NCT06313242 | Recruiting

• 1 other identifier: 202403
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetically Controlled Capsule Endoscopy; Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of completion of inspections

  1 day (Upon completion of the examination)

• Small intestine transit time

  1 day (Upon completion of the examination)

• Lesion detection rate

  1 day (Upon completion of the examination)

• Patient tolerance

  1 day (Upon completion of the examination)

• Rate of adverse events

  1 day (Upon completion of the examination)

Study Arms (3)

Laxatives arm

ACTIVE COMPARATOR

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)

Low residue diet arm

EXPERIMENTAL

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

Other: Low residue diet

Normal diet arm

EXPERIMENTAL

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

Other: Normal diet

Interventions

Polyethylene Glycol Electrolytes Powder (II) DRUG

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

Also known as: laxatives for bowel preparation

Laxatives arm

Low residue diet OTHER

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

Low residue diet arm

Normal diet OTHER

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

Normal diet arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, male or female
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 34752902 BACKGROUND

• 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.

  PMID: 37681236 BACKGROUND

• 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.

  PMID: 30005825 BACKGROUND

• 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.

  PMID: 37701026 BACKGROUND

• 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.

  PMID: 35037327 BACKGROUND

• 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.

  PMID: 29409067 BACKGROUND

• 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.

  PMID: 31482360 BACKGROUND

• 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.

  PMID: 26460222 BACKGROUND

MeSH Terms

Interventions

Laxatives

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Feixue Chen, Ph.D

CONTACT

18560086108; chenfeixue@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: March 14, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)