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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Low residue diet arm | Experimental | Low residue diet 1 day before the test, fasting from 20:00 pm. |
|
| Normal diet arm | Experimental | Normal diet 1 day before the test, fasting from 20:00 pm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol Electrolytes Powder (II) | Drug | Polyethylene Glycol Electrolytes Powder (II) was used for bowel preparation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of completion of inspections | The examination is considered complete when the capsule reaches the cecum. | 1 day (Upon completion of the examination) |
| Small intestine transit time | Time taken for the capsule to pass through the entire small intestine to reach the cecum. |
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Inclusion Criteria:
(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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feixue Chen, Ph.D | Contact | 18560086108 | chenfeixue@email.sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34752902 | Background | 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. | |
| 37681236 |
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| ID | Term |
|---|---|
| D054368 | Laxatives |
| ID | Term |
|---|---|
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Low residue diet | Other | Low residue diet 1 day before the test, fasting from 20:00 pm. |
|
| Normal diet | Other | Normal diet 1 day before the test, fasting from 20:00 pm. |
|
| 1 day (Upon completion of the examination) |
| 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) |
| 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) |
| 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) |
| 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. |
| 30005825 | 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. |
| 37701026 | 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. |
| 35037327 | 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. |
| 29409067 | 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. |
| 31482360 | 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. |
| 26460222 | 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. |