Effect of Simethicone on Colon Preparation During Water Exchange Colonoscopy

Официальное название

Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study

Обзор

Background: Colonoscopy reduces colorectal cancer mortality by enabling early detection and removal of adenomas. Its effectiveness, however, depends heavily on bowel preparation quality and mucosal visibility. Simethicone, an anti-foaming agent, decreases intraluminal bubbles and improves visualization; studies in conventional air-insufflation colonoscopy generally show benefits for cleanliness and patient comfort, but evidence in water-exchange (WE) colonoscopy remains limited.Objective: To evaluate whether adding oral simethicone to a split-dose polyethylene glycol (PEG) regimen further improves bowel cleanliness and procedural performance in WE colonoscopy.Methods: Adults undergoing outpatient colonoscopy will be randomly assigned (1:1) to a simethicone group or a control group, with a planned enrollment of 180 participants. All procedures will use the WE insertion technique, and endoscopists will be blinded to group allocation. The primary endpoint is the Boston Bowel Preparation Scale (BBPS); adequate preparation is defined as a total score ≥6 with all segment scores ≥2. Secondary endpoints include bubble score and CEBuS, adenoma detection rate (ADR), polyp detection rate (PDR), cecal intubation rate and time, withdrawal time, volume of water used and flushing/irrigation metrics, and patient-reported tolerability and satisfaction.Expected Results: Compared with PEG alone, adding simethicone is expected to (1) increase the proportion of adequate BBPS preparations, (2) reduce bubble coverage, (3) maintain or potentially improve ADR/PDR, and (4) enhance patient tolerability and satisfaction.Conclusion: If effective, this intervention would provide a simple, low-cost strategy to optimize the quality of WE colonoscopy.

Вмешательства

• Препарат Simethicone with PEG
  All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen. Participants in the simethicone group additionally received 30 mL of simethicone (600 mg), with 15 mL added to each 1-liter dose of PEG solution.
• Препарат PEG
  All participants followed a standardized bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution administered in a split-dose regimen.

Первичные конечные точки

• Boston bowel preparation scale (BBPS) [Срок оценки: At the time of colonoscopy.]

Вторичные конечные точки (11)

• Bubble score assessed using a 4-point bubble scale [Срок оценки: During the colonoscopy procedure.]
• Colon Endoscopic Bubble Scale(CEBuS) [Срок оценки: During the colonoscopy procedure.]
• Adenoma detection rate (ADR) [Срок оценки: one week]
• Polyp detection rate (PDR) [Срок оценки: one week]
• Cecal intubation rate [Срок оценки: At the time of colonoscopy.]
• Cecal intubation time [Срок оценки: During the colonoscopy procedure.]
• Withdrawal time [Срок оценки: During the colonoscopy procedure.]
• Volume of water infused [Срок оценки: During the procedure.]
• Volume of fluid aspirated [Срок оценки: During the procedure]
• Patient-reported pain score [Срок оценки: Immediately after the procedure.]
• Patient satisfaction score [Срок оценки: Immediately after the procedure.]

Критерии участия

Критерии включения

• Consecutive patients undergoing screening, surveillance, or diagnostic colonoscopy.
• Procedures performed by participating endoscopists.
• Ability to provide written informed consent.

Критерии исключения

• Colonoscopy performed using air insufflation or water immersion technique.
• History of colorectal surgery (e.g., colectomy or colostomy).
• Known or suspected colonic obstruction or severe stricture.
• Requirement for inpatient bowel preparation.
• Known allergy or hypersensitivity to simethicone.
• Unable or unwilling to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. doi: 10.3748/wjg.15.3032. PMID 19554657
• Cao RR, Wang L, Gao C, Pan JH, Yoshida EM, Li HY, Qi XS. Effect of oral simethicone on the quality of colonoscopy: A systematic review and meta-analysis of randomized controlled trials. J Dig Dis. 2022 Mar;23(3):134-148. doi: 10.1111/1751-2980.13084. Epub 2022 Mar 14. PMID 35075814
• Sun M, Yang G, Wang Y. Cleaning effect and tolerance of 16 bowel preparation regimens on adult patients before colonoscopy: a network meta-analysis. Int J Colorectal Dis. 2023 Mar 11;38(1):69. doi: 10.1007/s00384-023-04355-3. PMID 36905434
• Zhang S, Zheng D, Wang J, Wu J, Lei P, Luo Q, Wang L, Zhang B, Wang H, Cui Y, Chen M. Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial. Endoscopy. 2018 Apr;50(4):412-422. doi: 10.1055/s-0043-121337. Epub 2017 Nov 13. PMID 29132175
• Joao M, Areia M, Alves S, Elvas L, Brito D, Saraiva S, Cadime AT. The Effect of Oral Simethicone in a Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: A Randomized Controlled Trial. GE Port J Gastroenterol. 2023 Jun 15;31(2):116-123. doi: 10.1159/000530866. eCollection 2024 Apr. PMID 38572443
• Bai Y, Fang J, Zhao SB, Wang D, Li YQ, Shi RH, Sun ZQ, Sun MJ, Ji F, Si JM, Li ZS. Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6. PMID 28985630
• Moolla M, Dang JT, Shaw A, Dang TNT, Tian C, Karmali S, Sultanian R. Simethicone decreases bloating and improves bowel preparation effectiveness: a systematic review and meta-analysis. Surg Endosc. 2019 Dec;33(12):3899-3909. doi: 10.1007/s00464-019-07066-5. Epub 2019 Aug 26. PMID 31451919
• Menees SB, Elliott E, Govani S, Anastassiades C, Judd S, Urganus A, Boyce S, Schoenfeld P. The impact of bowel cleansing on follow-up recommendations in average-risk patients with a normal colonoscopy. Am J Gastroenterol. 2014 Feb;109(2):148-54. doi: 10.1038/ajg.2013.243. PMID 24496417

Идентификаторы

NCT: NCT07674160 · A11403003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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