Clinical trial NCT06317597: Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy
Official title: Evaluating the Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution: A Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Colonoscopy: Bowel Preparation
Keywords: time interval
bowel preparation
Oral Sulfate Solution（OSS）
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Tianjin Medical University General Hospital
name: The Affiliated Suzhou Hospital of Nanjing Medical University
name: Tianjin First Central Hospital
name: Tianjin Beichen Hospital
name: Shandong Provincial Hospital
name: The Affiliated Hospital of Qingdao University
name: First People's Hospital of Hangzhou
name: The Third People's Hospital of Chengdu
name: Ningbo Yinzhou District Second Hospital
name: Changshu Affiliated Hospital of Soochow University
name: Linyi People's Hospital
name: Shanghai East Hospital
name: Heilongjiang Province Hospital Nangang Branch
name: The Affiliated Jiangyin Hospital of Nantong University
name: West China Hospital
First posted: 2024-03-19
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bowel preparation adequate rate
timeFrame: 30minutes
Secondary outcomes:
measure: Acceptability of bowel preparation by questionnaire survey
timeFrame: 12 hours
Other outcomes:
measure: Incidence of laxative-related adverse events assessed by clinical examinations
timeFrame: 8 days
measure: Colonoscopy completion rate
timeFrame: 30 minutes
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References: