Cap-assisted endoscopic sclerotherapy for treating internal hemorrhoids and rectal prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.