Annals of internal medicine · 2026
Low-Volume Polyethylene Glycol for Bowel Preparation in Hospitalized Adults : A Multicenter Randomized Trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Frazzoni Leonardo, Cesaro Paola, Radaelli Franco, Fabbri Carlo, Guglielmo Simona, Mussetto Alessandro, Manno Mauro, Pugliano Cecilia Lina, Segatta Francesco, Pezzuto Edoardo, Raschi Emanuel, Facciorusso Antonio, Hassan Cesare, Spada Cristiano, Fuccio Lorenzo, INTERPRET Study Group
Аннотация
BACKGROUND: Adequate bowel preparation is essential for high-quality colonoscopy but remains challenging in hospitalized patients, and comparative data on preparation volume are limited.
OBJECTIVE: To compare the efficacy, tolerability, and safety of very low-volume (1-liter [1L]), low-volume (2-liter [2L]), and high-volume (4-liter [4L]) polyethylene glycol (PEG) regimens for inpatient colonoscopy preparation.
DESIGN: Multicenter, randomized controlled, endoscopist-blinded trial. (EudraCT: 2019-002799-15; ClinicalTrials.gov: NCT04708366).
SETTING: Community and academic hospitals in Italy.
PATIENTS: Hospitalized adults undergoing elective colonoscopy.
INTERVENTION: Patients were randomly assigned (1:1:1) to split-dose 1L PEG-ascorbate, 2L PEG-ascorbate, or 4L PEG.
MEASUREMENTS: Primary end point was adequate bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with all segments ≥2). Secondary end points included high-quality cleansing (BBPS score, 8 to 9), high-quality right-colon cleansing (BBPS score, 3), and willingness to repeat.
RESULTS: Among 665 randomly assigned patients (1L, n = 228; 2L, n = 218; 4L, n = 219), adequate overall cleansing occurred in 82.0%, 78.0%, and 78.5% (absolute difference between the 1L and 2L groups [Δ1L-2L], 4.0 percentage points [95% CI, -3.4 to 11.4 percentage points]; absolute difference between the 1L and 4L groups [Δ1L-4L], 3.5 percentage points [CI, -3.9 to 10.9 percentage points]). High-quality overall cleansing occurred in 46.9%, 35.3%, and 37.4% (Δ1L-2L, 11.6 percentage points [CI, 2.5 to 20.5 percentage points]; Δ1L-4L, 9.5 percentage points [CI, 0.3 to 18.5 percentage points]). High-quality right-colon cleansing occurred in 40.6%, 29.5%, and 31.6% (Δ1L-2L, 11.2 percentage points [CI, 2.1 to 20.0 percentage points]; Δ1L-4L, 9.0 percentage points [CI, 0.0 to 17.9 percentage points]). Tolerability was good across regimens, with the highest willingness to repeat in the 1L group (84.2%), despite more frequent vomiting and thirst.
LIMITATION: Patients requiring urgent colonoscopy for active gastrointestinal bleeding and those with severe/unstable comorbid conditions were excluded.
CONCLUSION: In hospitalized adults undergoing elective colonoscopy, 1L PEG-ascorbate yielded higher rates of high-quality cleansing, including right colon, than 2L PEG-ascorbate and 4L PEG, with similar rates of adequate cleansing and high willingness to repeat.
PRIMARY FUNDING SOURCE: Norgine Srl.
OBJECTIVE: To compare the efficacy, tolerability, and safety of very low-volume (1-liter [1L]), low-volume (2-liter [2L]), and high-volume (4-liter [4L]) polyethylene glycol (PEG) regimens for inpatient colonoscopy preparation.
DESIGN: Multicenter, randomized controlled, endoscopist-blinded trial. (EudraCT: 2019-002799-15; ClinicalTrials.gov: NCT04708366).
SETTING: Community and academic hospitals in Italy.
PATIENTS: Hospitalized adults undergoing elective colonoscopy.
INTERVENTION: Patients were randomly assigned (1:1:1) to split-dose 1L PEG-ascorbate, 2L PEG-ascorbate, or 4L PEG.
MEASUREMENTS: Primary end point was adequate bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with all segments ≥2). Secondary end points included high-quality cleansing (BBPS score, 8 to 9), high-quality right-colon cleansing (BBPS score, 3), and willingness to repeat.
RESULTS: Among 665 randomly assigned patients (1L, n = 228; 2L, n = 218; 4L, n = 219), adequate overall cleansing occurred in 82.0%, 78.0%, and 78.5% (absolute difference between the 1L and 2L groups [Δ1L-2L], 4.0 percentage points [95% CI, -3.4 to 11.4 percentage points]; absolute difference between the 1L and 4L groups [Δ1L-4L], 3.5 percentage points [CI, -3.9 to 10.9 percentage points]). High-quality overall cleansing occurred in 46.9%, 35.3%, and 37.4% (Δ1L-2L, 11.6 percentage points [CI, 2.5 to 20.5 percentage points]; Δ1L-4L, 9.5 percentage points [CI, 0.3 to 18.5 percentage points]). High-quality right-colon cleansing occurred in 40.6%, 29.5%, and 31.6% (Δ1L-2L, 11.2 percentage points [CI, 2.1 to 20.0 percentage points]; Δ1L-4L, 9.0 percentage points [CI, 0.0 to 17.9 percentage points]). Tolerability was good across regimens, with the highest willingness to repeat in the 1L group (84.2%), despite more frequent vomiting and thirst.
LIMITATION: Patients requiring urgent colonoscopy for active gastrointestinal bleeding and those with severe/unstable comorbid conditions were excluded.
CONCLUSION: In hospitalized adults undergoing elective colonoscopy, 1L PEG-ascorbate yielded higher rates of high-quality cleansing, including right colon, than 2L PEG-ascorbate and 4L PEG, with similar rates of adequate cleansing and high willingness to repeat.
PRIMARY FUNDING SOURCE: Norgine Srl.