Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

  • STATUS
    Recruiting
  • End date
    Mar 27, 2022
  • participants needed
    1000
  • sponsor
    The Second Hospital of Nanjing Medical University
Updated on 23 January 2021

Summary

This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).

Description

Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.

Details
Condition Rectal disorder, Rectal Prolapse, Rectal Disorders, Internal Hemorrhoid, Internal Hemorrhoids
Treatment Cap-assisted endoscopic sclerotherapy using long needle, Cap-assisted endoscopic sclerotherapy using short needle
Clinical Study IdentifierNCT03917056
SponsorThe Second Hospital of Nanjing Medical University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids
Patients with bowel preparation

Exclusion Criteria

History of anoscopic/endoscopic sclerotherapy
Patients with acute thrombotic external hemorrhoids
Patients with serious internal hemorrhoids of grade IV
Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease
Patients with acute diarrhea in the past 24 hours
Hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis
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