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Methylene Blue Staining Efficacy and Lesion Detection Rate in Colonoscopy

Clinical Study on the Staining Effect and Lesion Detection Rate of Methylen Blue Sustained-release Tablets

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128333
Enrollment
Unknown
Registered
2026-07-17
Start date
2025-07-21
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

colorectal tumor

Interventions

experimental group:Taking polyethylene glycol intestinal cleanser
control group:Take magnesium sodium potassium sulfate intestinal cleanser

Sponsors

Wuhan Puren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. At the time of signing the informed consent form, participants must be between 45 and 75 years old (inclusive). 2. Participants scheduled for colorectal tumor screening or surveillance via colonoscopy.

Exclusion criteria

Exclusion criteria: 1. Individuals with contraindications to colonoscopy or oral methylene blue enteric-coated sustained-release tablets; 2. Pregnant or breastfeeding women; 3. Presence of significant CRC alarm symptoms or signs (e.g., hematochezia, melena, unexplained anemia, weight loss, abdominal mass, or positive digital rectal examination); 4. History of colorectal resection; 5. Known active inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) in acute exacerbation, or conditions that may hinder complete colonoscopy, such as severe colorectal stenosis, intestinal obstruction or suspected obstruction, toxic megacolon, gastric retention, or intestinal perforation; 6. Use of antiplatelet medications (e.g., aspirin or clopidogrel) within 7 days prior to colonoscopy; 7. Participants with confirmed G6PD deficiency; 8. Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants at screening; 9. Severe cardiovascular diseases (e.g., heart failure NYHA Class III-IV) or hepatic/renal insufficiency (e.g., eGFR <30 mL/min/1.73m², Child-Pugh Class C);

Design outcomes

Primary

MeasureTime frame
Methylene blue staining score;

Secondary

MeasureTime frame
Adenoma detection rate;Boston Bowel Preparation Scale, BBPS;

Countries

China

Contacts

Public ContactHuang Linfei

Wuhan Puren Hospital

355757931@qq.com+86 136 2724 6143

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026