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Adenoma detection rate and tolerability of 2 ultra-low-volume bowel preparations in screening: a noninferiority randomized controlled trial.
Serradesanferm, Anna; Torá-Rocamora, Isabel; Pozo, Àngels; Ocaña, Teresa; Diaz, Mireia; Moreira, Rebeca; Rivero-Sánchez, Liseth; Ortiz, Oswaldo; Carballal, Sabela; Moreira, Leticia; Vaquero, Eva C; Ordás, Ingrid; Bayarri, Carolina; Daca-Alvarez, Maria; Torres, Sonia; Grau, Jaume; Balaguer, Francesc; Castells, Antoni; Pellisé, Maria.
Afiliação
  • Serradesanferm A; Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; ISGlobal, Barcelona, Spain.
  • Torá-Rocamora I; Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain; ISGlobal, Barcelona, Spain; University of Barcelona, Barcelona, Spain.
  • Pozo À; Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; ISGlobal, Barcelona, Spain.
  • Ocaña T; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain.
  • Diaz M; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
  • Moreira R; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain.
  • Rivero-Sánchez L; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Ba
  • Ortiz O; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
  • Carballal S; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Ba
  • Moreira L; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Ba
  • Vaquero EC; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
  • Ordás I; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
  • Bayarri C; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain.
  • Daca-Alvarez M; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
  • Torres S; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain.
  • Grau J; Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain; ISGlobal, Barcelona, Spain; University of Barcelona, Barcelona, Spain.
  • Balaguer F; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Ba
  • Castells A; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Ba
  • Pellisé M; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; University of Barcelona, Barcelona, Spain; Department of Gastroenterology, Hospital Clinic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Ba
Gastrointest Endosc ; 2024 Jul 26.
Article em En | MEDLINE | ID: mdl-39069266
ABSTRACT
BACKGROUND AND

AIMS:

The adenoma detection rate (ADR), recognized as a surrogate marker for colorectal cancer (CRC) incidence and mortality reduction, is closely linked to the efficacy of bowel cleansing. However, there is a dearth of evidence examining the impact on ADR when using 2 distinct very-low-dose bowel cleansing products. This study sought to compare ADR in an immunochemical fecal occult blood test (iFOBT)-based organized screening program by using 1 L of polyethylene glycol plus ascorbate (1L-PEGA) versus sodium picosulfate with magnesium citrate (SPMC), both administered in a split-dose regimen.

METHODS:

We conducted a comparative, parallel, randomized, noninferiority, and low-intervention clinical trial targeting individuals from a population CRC screening program aged 50 to 69 years with a positive iFOBT result scheduled for a workup colonoscopy in the morning. Participants were randomized to either 1L-PEGA or SPMC for bowel cleansing. The main outcome was ADR, whereas secondary outcomes were bowel preparation quality, safety, tolerability, and satisfaction.

RESULTS:

A total of 1002 subjects, 501 were included in each group. There were no differences between groups with respect to pooled ADR (SPMC, 56.5% [95% CI, 52.1-60.8]; 1L-PEGA, 53.7% [95% CI, 49.3-58.0]; relative risk, .95 [95% CI, .85-1.06]); therefore, SPMC demonstrated noninferiority in ADR compared with 1L-PEGA (difference, 2.8%; 2-sided 95% lower confidence limit, -3.4). In addition, there were no significant differences in mean lesions regardless of size and location between arms. Bowel preparation favored 1L-PEGA (96.2% vs 89.2%, P < .001), whereas SPMC exhibited significantly higher safety and tolerability, as shown by fewer nonserious treatment-emergent adverse events.

CONCLUSIONS:

SPMC emerged as a noninferior laxative compared with 1L-PEGA concerning ADR. Despite the superior bowel preparation quality associated with 1L-PEGA, the safety, tolerability, and overall satisfaction of participants were higher with SPMC. (Clinical trial registration number EudraCT 2019-003186-18.).

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article