Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2025-03-27

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Internal Hemorrhoid Rectal Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Long needle group

Participants were treated with CAES using long needle.

Group Type EXPERIMENTAL

Cap-assisted endoscopic sclerotherapy using long needle

Intervention Type PROCEDURE

Participants were treated with CAES using long needle.

Short needle group

Participants were treated with CAES using short needle.

Group Type EXPERIMENTAL

Cap-assisted endoscopic sclerotherapy using short needle

Intervention Type PROCEDURE

Participants were treated with CAES using short needle.

Interventions

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Cap-assisted endoscopic sclerotherapy using long needle

Participants were treated with CAES using long needle.

Intervention Type PROCEDURE

Cap-assisted endoscopic sclerotherapy using short needle

Participants were treated with CAES using short needle.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No