| Autor: |
Kinichi Hotta, Yosuke Otake, Daisuke Yamaguchi, Yuichi Shimodate, Norihiro Hanabata, Hiroaki Ikematsu, Yohei Yabuuchi, Yasushi Sano, Ryo Shimoda, Shinya Sugimoto, Mari Oba, Hiroyuki Takamaru, Kouichiro Kimura, Yoshihiro Kishida, Kazunori Takada, Sayo Ito, Kenichiro Imai, Kazuya Hosotani, Tatsuro Murano, Masayoshi Yamada, Kensuke Shinmura, Rio Takezawa, Michito Tomonaga, Yutaka Saito |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
BMC Gastroenterology, Vol 24, Iss 1, Pp 1-10 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
1471-230X |
| DOI: |
10.1186/s12876-024-03146-6 |
| Popis: |
Abstract Background Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. Methods This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40–69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. Discussion This trial aims to develop a “patient-first” colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. Trial registration Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023). |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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