Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy

Colonoscopy: Bowel Preparation Clinical Trial

Official title:

Evaluating the Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution: A Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06317597
• Other study ID #: OSS2024-0311
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 448
• Est. completion date: December 30, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy: Bowel Preparation

Intervention

Drug:
• Magnesium 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.
• Magnesium 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 sulfates oral solution to 500ml and intake 16-18 hours before the colonoscopy, followed by two doses of 500ml water or clear aqueous liquid within 2 hours; Repeat the procedure 6 hours before the colonoscopy.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (17)

Lead Sponsor

Collaborator

Changhai Hospital

Changshu Affiliated Hospital of Soochow University, First People's Hospital of Hangzhou, Heilongjiang Province Hospital Nangang Branch, Internet Hospital of Tianjin Medical University General Hospital, Linyi People's Hospital, Ningbo Yinzhou District Second Hospital, Peking University People's Hospital, ShangDong Provincial Hospital, Shanghai East Hospital, The Affiliated Hospital of Qingdao University, The Affiliated Jiangyin Hospital of Nantong University, The Affiliated Suzhou Hospital of Nanjing Medical University, The Third People's Hospital of Chengdu, Tianjin Beichen Hospital, Tianjin First Central Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of laxative-related adverse events assessed by clinical examinations		8 days
Other	Colonoscopy completion rate	Proportion of subjects receiving complete colonoscopy	30 minutes
Primary	Bowel preparation adequate rate	Adequate bowel cleansing was defined as a total Boston Bowel Preparation Scale (BBPS) = 6 with a partial BBPS = 2 in each colon segment.	30minutes
Secondary	Acceptability of bowel preparation by questionnaire survey		12 hours