Application of Oral Sulphate Solution As New Bowel Cleansing Agent Before Colonoscopy in China Populations: A Post-Marketing, Prospective, Multicentor, Real World Study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500104362

Enrollment

Unknown

Registered

2025-06-16

Start date

2024-06-24

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Observation group:NA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Provision of written informed consent signed prior to any study related procedures; 2.Male or female, at least 18 years old undergoing colonoscopy for a routine colonoscopy indication; 3.No significant of electrolyte disturbance clinical significance; 4.Receive OSS as bowel preparation agent before colonoscopy; 5.Subjects requiring colonoscopy due to clinical routine early CRC screening.

Exclusion criteria

Exclusion criteria: 1.Emergency colonoscopy test; 2.AI-assisted colonoscopy; 3.Reject or not sign the ICF; 4.Receive other bowel cleansing agents before colonoscopy; 5.Not applicate for this study assessed by investigators; 6.Less than 18 years old; 7.Pregnant or lactating; 8.Therapeutic colonoscopy, eg polypectomy; 9.Patients who have previously undergone colorectal surgery; 10.Water exchange colonoscopy; 11.Hypersensitivity to any of the excipients; 12. Congestive heart failure; 13. Serious deteriorations in general health such as severe dehydration; 14.Severe active inflammatory bowel disease (e.g., Crohn’s disease and ulcerative colitis); 15.Known or suspected gastrointestinal perforation; 16.Toxic colitis or toxic megacolon; 17.Known or suspected ileus; 18.Known or suspected gastrointestinal obstruction or stenosis; 19. Disorders of gastric emptying (e.g.: gastroparesis, gastric stasis); 20.Acute abdominal disorders subject to surgery such as acute appendicitis; 21.Nausea and vomiting; 22.Ascites; 23.Severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2);

Design outcomes

Primary

Measure	Time frame
Success rate of bowel preparation;	—

Secondary

Measure	Time frame
The detection rate of Polyp and adenoma ;The impact factors on OSS excellent bowel preparation as bowel preparation agents;The patients stool characteristics ;The patients adherence; The patients safety assessment;The patients feedback;	—

Countries

China

Contacts

Public ContactYang Aiming

Gastroenterology Department of Peking Union Medical College Hospital

yangaiming@medmail.com.cn+86 10 6915 1591

Outcome results