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Effect of Simethicone on Colon Preparation During Water Exchange Colonoscopy

23. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Boston bowel preparation scale (BBPS)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bubble score assessed using a 4-point bubble scale
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: one week
one week
Polyp detection rate (PDR)
Tidsramme: one week
one week
Cecal intubation rate
Tidsramme: At the time of colonoscopy.
Proportion of procedures in which the cecum is successfully reached.
At the time of colonoscopy.
Cecal intubation time
Tidsramme: During the colonoscopy procedure.
Time from insertion to successful cecal intubation, measured in minutes.
During the colonoscopy procedure.
Withdrawal time
Tidsramme: During the colonoscopy procedure.
Time from cecal intubation to scope withdrawal, measured in minutes.
During the colonoscopy procedure.
Volume of water infused
Tidsramme: During the procedure.
Total volume of water infused during colonoscopy, measured in milliliters.
During the procedure.
Volume of fluid aspirated
Tidsramme: During the procedure
Total volume of fluid aspirated during colonoscopy, measured in milliliters.
During the procedure
Patient-reported pain score
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

3. marts 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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