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A prospective, randomized and endoscopist-blinded trial to evaluate comparable efficacy of a 1-L PEG and ascorbic acid with sennoside versus a 2-L PEG and ascorbic acid for bowel preparation (Senno trial)

Trial to evaluate comparable efficacy of a 1-L PEG and ascorbic acid with sennoside versus a 2-L PEG and ascorbic acid for bowel preparation (Senno trial)

344

There were no significant differences in age, gender, BMI, grade of education, comorbidities, and chronic constipation. Age, years; 68 (57-73) and 67 (57-73), Male/Female; 89/83 and 92/80, BMI, kg/m2; 23 (21-26) and 24 (21-26), Grade of education (Junior high school or less); 32 (19%) and 30 (17%), Comorbidities (Diabetes mellitus); 20 (12%) and 15 (9%), Comorbidities (Hypertension); 76 (44%) and 62 (36%). (1L-PEG/AS and 2L-PEG/A) (Data are n(%) or median (IQR))

Among 786 patients scheduled to undergo colonoscopy, 344 patients were randomized 1:1 to the 1L-PEG/AS group (n=172) or the 2L-PEG/A group (n=172). Among 344 patients eligible for this study, two in the 1L-PEG/AS group and three in 2L-PEG/A group cancelled the examination after randomization (1% vs. 2%). Ultimately, 170 in the 1L-PEG/AS group and 169 in the 2L-PEG/A group were included in the PP analysis.

Nausea, vomiting, abdominal pain and discomfort, and quality of sleep, were comparable between the two groups. No patients experienced moderate-to-severe abdominal pain and ischemic colitis.

The 1L-PEG/AS group showed non-inferior adequate BP rates compared with the 2L-PEG/A group (88% vs. 89%, P=1.00); Higher willingness to repeat the BP was observed in the 1L-PEG/AS group (85% vs. 62%, P<0.01).

The 1L-PEG/AS regimen was comparable to the 2L-PEG/A regimen in terms of BP adequacy, requiring lesser BP solution volumes, with better patient tolerance.

Oct. 05, 2023

Sept. 01, 2023

https://onlinelibrary.wiley.com/doi/full/10.1111/den.14504

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCT1051220043

Fukuda Takashi

Minami Osaka Hospital

1-18-18 Higashikagaya, Suminoe-ku, Osaka

t.fukuda@minamiosaka.com

Morimoto Kenichi

Minami Osaka Hospital

1-18-18 Higashikagaya, Suminoe-ku, Osaka

+81-6-6685-0221

kenichi.morimoto@gmail.com

Complete

June. 10, 2022

Interventional

randomized controlled trial

single blind

active control

parallel assignment

other

1) patients who were scheduled for elective colonoscopy
2) patients who aged over 20 years old and under 85 years old
3) patients who were able to fill in the informed consent form for participation

1) severe heart failure (NYHA class III or IV)
2) severe hepatic failure (Child-Pugh C)
3) active inflammatory bowel disease
4) dementia
5) allergy to Moviprep or sennoside
6) advanced colorectal cancer
7) intestinal resection
8) past history of participance in this study

Both

patients who require colonoscopy

Patients receive 2-L PEG-Asc or sennoside 24 mg prior to 1-L PEG-Asc.

colonoscopy

Solution, Bowel Preparation

D003113

D002400

inadequate bowel preparation rate scored by Boston Bowel Preparation Scale (BBPS)

procedure-related parameters, safety and tolerability

+81-6-6685-0221

Nov. 04, 2021

none