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Recruiting NCT04169152

CAES for Internal Hemorrhoids and Rectal Prolapse

Trial Parameters

Condition Internal Hemorrhoid
Sponsor Faming Zhang
Study Type OBSERVATIONAL
Phase N/A
Enrollment 10,000
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2019-12-30
Completion 2027-12-30
Interventions
Cap-assisted endoscopic sclerotherapy

Brief Summary

Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.

Eligibility 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.

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