RecruitingNCT04169152

CAES for Internal Hemorrhoids and Rectal Prolapse

Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study


Sponsor

Faming Zhang

Enrollment

10,000 participants

Start Date

Dec 30, 2019

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study evaluates a procedure called CAES (Colonoscopic Assisted Endoscopic Sclerotherapy) for treating internal hemorrhoids and rectal prolapse. Hemorrhoids are swollen veins inside the rectum that can cause bleeding, discomfort, and prolapse. Sclerotherapy involves injecting a solution into hemorrhoidal tissue to shrink it. The study tests how safe and effective this endoscopic technique is for Grade I–III internal hemorrhoids and rectal prolapse, potentially offering an alternative to more invasive surgical procedures. You may be eligible if: - You have Grade I, II, or III internal hemorrhoids (with or without external hemorrhoids) and/or rectal prolapse - You have completed bowel preparation You may NOT be eligible if: - You have previously had anoscopic or endoscopic sclerotherapy - You have acute thrombotic hemorrhoids or Grade IV internal hemorrhoids - You have anal stenosis, perianal abscess, anal fissure, fistula, fecal incontinence, or other severe anal complications - You have inflammatory bowel disease - You have full-thickness rectal prolapse through the anus - You had acute diarrhea in the past 24 hours - You have high blood pressure that is not well controlled - You have had a stroke (cerebrovascular accident) - You have a blood clotting disorder - You are pregnant - You have a mental disorder - You have decompensated cirrhosis (advanced liver failure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECap-assisted endoscopic sclerotherapy

Cap-assisted endoscopic sclerotherapy (CAES) is an innovation technique for having advantages in accurately controlling the injection angle, direction, depth under direct vision of flexible endoscope.


Locations(1)

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT04169152


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