Colonoscopy: Bowel Preparation
Conditions
Keywords
time interval, bowel preparation, Oral Sulfate Solution（OSS）
Brief summary
To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality.
Detailed description
The split-dose bowel preparation is recommended by multiple guidelines and widely used worldwide for improved bowel preparation quality, higher detection rate of colorectal lesions, and better tolerance. The effect of the time interval between the last dose of laxative and the colonoscopy on the quality of bowel preparation has been well studied, but the impact of the time interval between the first and last dose of laxative on the bowel preparation quality deserve to be explored. Oral sulfate solution administered in a short time interval can reduce sleep disturbance and hunger and is more flexible and convenient. This study aims to evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) is not inferior to a long time interval (10-12 hours) on bowel preparation quality.
Interventions
DRUGMagnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution
OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Dilute 177ml sodium, potassium, and magnesium sulfate oral solution to 500ml and intake 12-14 hours before colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.
Sponsors
Peking University People's Hospital
Tianjin Medical University General Hospital
The Affiliated Suzhou Hospital of Nanjing Medical University
Tianjin First Central Hospital
Tianjin Beichen Hospital
Shandong Provincial Hospital
The Affiliated Hospital of Qingdao University
First People's Hospital of Hangzhou
The Third People's Hospital of Chengdu
Ningbo Yinzhou District Second Hospital
Changshu Affiliated Hospital of Soochow University
Linyi People's Hospital
Shanghai East Hospital
Heilongjiang Province Hospital Nangang Branch
The Affiliated Jiangyin Hospital of Nantong University
West China Hospital
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Voluntarily participate and sign informed consent; * Subjects who require screening, surveillance, and diagnostic colonoscopy; * Subjects who take the oral sulfate solution for bowel preparation.
Exclusion criteria
* Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, renal or liver dysfunction; * Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration. * Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding; * Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon. * Subjects who had previously undergone colorectal resection. * Subjects with constipation or suspected severe gastric motility disorder; * Women with positive pregnancy tests or pregnancy plans, and women in lactation; * Subjects who have participated in any other clinical trials within the last 3 months; * Subjects with any other conditions that the investigator considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation adequate rate | 30minutes | Adequate bowel cleansing was defined as a total Boston Bowel Preparation Scale (BBPS) ≥ 6 with a partial BBPS ≥ 2 in each colon segment. |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of bowel preparation by questionnaire survey | 12 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of laxative-related adverse events assessed by clinical examinations | 8 days | — |
| Colonoscopy completion rate | 30 minutes | Proportion of subjects receiving complete colonoscopy |
Countries
China
Outcome results
None listed