CAES for Internal Hemorrhoids and Rectal Prolapse

Recruiting now

Conditions studied: Internal Hemorrhoid, Rectal Prolapse

In brief

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.

Key facts

Study ID: NCT04169152
Run by: Faming Zhang
People needed: 10000
Starts: 2019-12-30
Expected to finish: 2028-06-30
Last updated by the study team: 2024-04-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
Patients with bowel preparation.

You may not qualify if…

History of anoscopic/endoscopic sclerotherapy.
Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
Inflammatory bowel disease.
Full-thickness rectal prolapse through the anus.
Acute diarrhea in the past 24 hours.
Hypertensive with uncontrolled blood pressure.
Cerebrovascular accident.
Blood coagulation dysfunction.
Pregnant women.
Mental disorders.
Decompensated cirrhosis.

Where it is running

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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