Publications

Journal Article Ahead of print

PubMed: 42081822 DOI: 10.7326/ANNALS-25-05005

Low-Volume Polyethylene Glycol for Bowel Preparation in Hospitalized Adults : A Multicenter Randomized Trial.

Ann Intern Med

Authors: Leonardo Frazzoni, Paola Cesaro, Franco Radaelli, Carlo Fabbri, Simona Guglielmo, Alessandro Mussetto, Mauro Manno, Cecilia Lina Pugliano, Francesco Segatta, Edoardo Pezzuto, Emanuel Raschi, Antonio Facciorusso, Cesare Hassan, Cristiano Spada, Lorenzo Fuccio

Affiliations

  • Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; and Gastroenterology and Endoscopy Unit, Rimini, Italy (L.Frazzoni).
  • Gastroenterology and Digestive Endoscopy Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy (P.C. C.L.P. E.P.).
  • Department of Gastroenterology, Valduce Hospital, Como, Italy (F.R. F.S.).
  • Digestive Endoscopy and Gastroenterology Unit, Forlì-Cesena Hospitals, Azienda Unita Sanitaria Locale della Romagna, Forlì-Cesena, Italy (C.F.).
  • Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola, Italy (S.G.).
  • Gastroenterology Unit, Azienda Unità Sanitaria Locale della Romagna, Santa Maria delle Croci Hospital, Ravenna, Italy (A.M.).
  • Gastroenterology and Digestive Endoscopy Unit, Azienda USL di Modena, Modena, Italy (M.M.).
  • Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy (E.R.).
  • Gastroenterology Unit, Department of Experimental Medicine, University of Salento, Lecce, Italy. (A.F.).
  • Department of Biomedical Sciences, Humanitas University, Milan; and Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Milan, Italy (C.H.).
  • Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome; and Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica Del Sacro Cuore di Roma, Rome, Italy (C.S.).
  • Department of Medical and Surgical Sciences, University of Bologna, Bologna; and Gastroenterology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (L.Fuccio).

Abstract

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.

MeSH

Internal Medicine, Colon, Polyethylene, Polyethylene Glycols, Colonoscopy