Cap-assisted endoscopic sclerotherapy for treating internal hemorrhoids and rectal prolapse
Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study
This study is testing a new method using a special cap during sclerotherapy to see if it can safely and effectively treat people with internal hemorrhoids and rectal prolapse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT04169152 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of cap-assisted endoscopic sclerotherapy (CAES) for patients with internal hemorrhoids and rectal prolapse. The innovative procedure utilizes a cap on the colonoscope to enhance visibility and precision during treatment, allowing for accurate injections while minimizing patient discomfort and potential complications. The study aims to gather large-scale data to confirm the long-term effectiveness of CAES, building on promising pilot results that showed sustained clinical efficacy within three months and no severe complications. By conducting this nationwide multi-center study, researchers hope to provide reliable evidence for the broader adoption of this minimally invasive technique.
Who should consider this trial
Good fit: Ideal candidates include individuals with Grade I-III internal hemorrhoids or rectal prolapse who have undergone bowel preparation.
Not a fit: Patients with severe complications such as acute thrombotic hemorrhoids, inflammatory bowel disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more effective treatment option for patients suffering from internal hemorrhoids and rectal prolapse.
How similar studies have performed: While pilot studies have shown promising results for CAES, this nationwide study aims to confirm its long-term efficacy and safety, making it a significant step in evaluating this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse. 2. Patients with bowel preparation. Exclusion Criteria: 1. History of anoscopic/endoscopic sclerotherapy. 2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids. 3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain). 4. Inflammatory bowel disease. 5. Full-thickness rectal prolapse through the anus. 6. Acute diarrhea in the past 24 hours. 7. Hypertensive with uncontrolled blood pressure. 8. Cerebrovascular accident. 9. Blood coagulation dysfunction. 10. Pregnant women. 11. Mental disorders. 12. Decompensated cirrhosis.
Where this trial is running
Nanjing, Jiangsu
- Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Faming Zhang, MD,PhD
- Email: fzhang@njmu.edu.cn
- Phone: 02558509884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.