Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy
Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients
Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.
Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Qinghai
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Xining, Qinghai, China, 810000
- Department of gastroenterology, Qinghai Provincial People's Hospital
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Department of gastroenterology, Shaanxi Second People's Hospital
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Shanxi
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Xi'an, Shanxi, China, 710032
- Endoscopic center, Xijing Hospital of Digestive Diseases
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients undergoing colonoscopy;
Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):
- Constipation
- Diabetes
- Parkinson's disease
- History of stroke or spine cord injure
- Prior history of inadequate bowel preparation
- BMI>25
- Use of tricyclic antidepressant or narcotics
Exclusion Criteria:
- History of colorectal resection;
- Suspected colonic stricture or perforation;
- Incomplete or complete bowel obstruction;
- Use of prokinetic agents or purgatives within 7 days;
- Toxic colitis or megacolon;
- Pregnancy or lactation;
- Unable to give informed consent;
- Haemodynamically unstable.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Single dose of 2L PEG
2 L of PEG solution was used on the day of colonoscopy.
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Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy.
Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.
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Actieve vergelijker: Split-dose of 4L PEG
Split-dose of 4l PEG was used before and on the day of colonoscopy
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All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy.
the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes.
On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
Tijdsspanne: 1 year
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The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side.
They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios.
The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Intrekking tijd
Tijdsspanne: 1 jaar
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1 jaar
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Polyp detection rate
Tijdsspanne: 1 year
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1 year
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Rate of adverse events
Tijdsspanne: 1 year
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adverse events, such as vomiting, nausea, headache, abdominal pain
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1 year
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Cecal intubation rate
Tijdsspanne: 1 year
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1 year
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Cecal intubation time
Tijdsspanne: 1 year
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1 year
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Willingness to repeat bowel preparation
Tijdsspanne: 1 year
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The number of patients have a willingness to undergo a repeated bowel preparation if needed
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1 year
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- KY20162097-5
Plan Individuele Deelnemersgegevens (IPD)
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