Electrolyte Beverage Combined With Polyethylene Glycol for Colonoscopy Bowel Preparation
24. maj 2026 opdateret af: Nanfang Hospital, Southern Medical University
Randomized Controlled Trial of Different Ratios of Electrolyte Beverage and Water Combined With Polyethylene Glycol on Bowel Preparation Quality and Ingestion Rhythm Before Colonoscopy
This randomized controlled trial aims to evaluate the effects of different ratios of electrolyte beverage and water combined with polyethylene glycol (PEG) on bowel preparation quality before colonoscopy.
Participants undergoing elective colonoscopy will be randomly assigned to one of three bowel preparation regimens: PEG prepared with water only, PEG prepared with a low ratio of electrolyte beverage and water, or PEG prepared with a medium ratio of electrolyte beverage and water.
The primary outcome is adequate bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS).
Secondary outcomes include bowel preparation completion rate, tolerability, adverse events, repeat colonoscopy rate, adenoma detection rate, and ingestion rhythm characteristics during bowel preparation.
This study also aims to explore whether electrolyte beverage-assisted bowel preparation may improve bowel cleansing quality by influencing participants' ingestion rhythm and adherence during PEG intake.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
405
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Aimin Li
- Telefonnummer: +86 13580317630
- E-mail: lam0725@163.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- Rekruttering
- Nanfang Hospital, Southern Medical University
-
Kontakt:
- Aimin Li
- Telefonnummer: +86 13580317630
- E-mail: lam0725@163.com
-
-
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:
- Adults aged 18-75 years scheduled to undergo elective colonoscopy
- Meet the standard clinical indications for colonoscopy;
- Able to understand and comply with the bowel preparation procedure and complete oral polyethylene glycol (PEG) intake as required;
- Able to comply with study-related data collection and follow-up;
- Provide written informed consent voluntarily.
Exclusion Criteria:
- Previously diagnosed colorectal cancer, intestinal obstruction, or suspected intestinal obstruction;
- Active gastrointestinal bleeding or a definite history of gastrointestinal bleeding within the past 4 weeks (including melena, hematochezia, or hematemesis);
- Severe renal insufficiency, decompensated heart failure, significant electrolyte imbalance, or other conditions unsuitable for PEG bowel preparation;
- Known allergy to polyethylene glycol or components of the electrolyte beverage used in the study;
- Pregnant or breastfeeding women;
- Any other condition considered by the investigators to make the participant unsuitable for the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Water Group
Participants receive polyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.
|
Polyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.
|
|
Eksperimentel: Low-dose Electrolyte Beverage Group
Participants receive polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.
|
Polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.
|
|
Eksperimentel: Medium-dose Electrolyte Beverage Group
Participants receive polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.
|
Polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adequate Bowel Preparation Rate
Tidsramme: At the time of colonoscopy on Day 1
|
Adequate bowel preparation is defined as a total Boston Bowel Preparation Scale (BBPS) score ≥6 with each colonic segment score ≥2 during colonoscopy.
|
At the time of colonoscopy on Day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Boston Bowel Preparation Scale Score
Tidsramme: At the time of colonoscopy on Day 1
|
Total Boston Bowel Preparation Scale (BBPS) score assessed during colonoscopy.
|
At the time of colonoscopy on Day 1
|
|
Bowel Preparation Completion Rate
Tidsramme: During bowel preparation within 1 hour before colonoscopy on Day 1
|
Proportion of participants who complete the planned polyethylene glycol bowel preparation within 60 minutes.
|
During bowel preparation within 1 hour before colonoscopy on Day 1
|
|
Adverse Event Rate
Tidsramme: During bowel preparation within 1 hour before colonoscopy on Day 1
|
Incidence of adverse events during bowel preparation, including nausea, vomiting, abdominal distension, abdominal pain, dizziness, and fatigue.
|
During bowel preparation within 1 hour before colonoscopy on Day 1
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
18. maj 2026
Primær færdiggørelse (Anslået)
31. januar 2027
Studieafslutning (Anslået)
31. maj 2027
Datoer for studieregistrering
Først indsendt
18. maj 2026
Først indsendt, der opfyldte QC-kriterier
24. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NFEC-2026-307
Plan for individuelle deltagerdata (IPD)
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