Effect of Simethicone on Colon Preparation During Water Exchange Colonoscopy
23 juin 2026 mis à jour par: Dalin Tzu Chi General Hospital
Effects of Simethicone on Colon Preparation in Water Exchange Colonoscopies: a Randomized Controlled Study
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
180
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Chih -Wei Tseng
- Numéro de téléphone: +886-5-2648000
- E-mail: cwtseng2@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Consecutive patients undergoing screening, surveillance, or diagnostic colonoscopy.
- Procedures performed by participating endoscopists.
- Ability to provide written informed consent.
Exclusion Criteria:
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Without simethicone group
follow a bowel preparation protocol consisting of 10 mg of bisacodyl and 2 liters of PEG solution.
|
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.
|
|
Expérimental: With simethicone group
Participants received a total of 30 mL of simethicone, with 15 mL added to each 1-liter dose of polyethylene glycol (PEG) solution in the split-dose regimen.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Boston bowel preparation scale (BBPS)
Délai: At the time of colonoscopy.
|
Bowel preparation quality assessed using the Boston Bowel Preparation Scale (BBPS).
Adequate preparation is defined as a total score ≥6 with all segment scores ≥2.
|
At the time of colonoscopy.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bubble score assessed using a 4-point bubble scale
Délai: During the colonoscopy procedure.
|
Bubble score assessed during colonoscopy using a 4-point scale (0-3) for each colon segment, where higher scores indicate more bubbles.
|
During the colonoscopy procedure.
|
|
Colon Endoscopic Bubble Scale(CEBuS)
Délai: During the colonoscopy procedure.
|
Bowel cleanliness assessed using the Colon Endoscopic Bubble Scale (CEBuS), categorized based on the percentage of mucosal surface obscured by bubbles (e.g., <5%, 5-50%, >50%).Higher scores indicate poorer visibility due to bubbles.
|
During the colonoscopy procedure.
|
|
Adenoma detection rate (ADR)
Délai: one week
|
one week
|
|
|
Polyp detection rate (PDR)
Délai: one week
|
one week
|
|
|
Cecal intubation rate
Délai: At the time of colonoscopy.
|
Proportion of procedures in which the cecum is successfully reached.
|
At the time of colonoscopy.
|
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Cecal intubation time
Délai: During the colonoscopy procedure.
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Time from insertion to successful cecal intubation, measured in minutes.
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During the colonoscopy procedure.
|
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Withdrawal time
Délai: During the colonoscopy procedure.
|
Time from cecal intubation to scope withdrawal, measured in minutes.
|
During the colonoscopy procedure.
|
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Volume of water infused
Délai: During the procedure.
|
Total volume of water infused during colonoscopy, measured in milliliters.
|
During the procedure.
|
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Volume of fluid aspirated
Délai: During the procedure
|
Total volume of fluid aspirated during colonoscopy, measured in milliliters.
|
During the procedure
|
|
Patient-reported pain score
Délai: Immediately after the procedure.
|
Pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
|
Immediately after the procedure.
|
|
Patient satisfaction score
Délai: Immediately after the procedure.
|
Patient satisfaction assessed using a numeric rating scale from 0 to 10, where higher scores indicate greater satisfaction.
|
Immediately after the procedure.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
- Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Sharma P, Burke CA, Johnson DA, Cash BD. The importance of colonoscopy bowel preparation for the detection of colorectal lesions and colorectal cancer prevention. Endosc Int Open. 2020 May;8(5):E673-E683. doi: 10.1055/a-1127-3144. Epub 2020 Apr 17.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 mai 2028
Achèvement de l'étude (Estimé)
1 septembre 2028
Dates d'inscription aux études
Première soumission
3 mars 2026
Première soumission répondant aux critères de contrôle qualité
23 juin 2026
Première publication (Réel)
29 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juin 2026
Dernière vérification
1 février 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A11403003
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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