Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

Study Overview
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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).

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.

Official Title
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Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a Nationwide Multicenter Randomized Controlled Trial

Conditions
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Internal Hemorrhoid, Rectal Prolapse

Intervention / Treatment
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* Procedure: Cap-assisted endoscopic sclerotherapy using long needle
* Procedure: Cap-assisted endoscopic sclerotherapy using short needle


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long needle group<br>Participants were treated with CAES using long needle. | Procedure: Cap-assisted endoscopic sclerotherapy using long needle<br>* Participants were treated with CAES using long needle.<br>|
| Experimental: Short needle group<br>Participants were treated with CAES using short needle. | Procedure: Cap-assisted endoscopic sclerotherapy using short needle<br>* Participants were treated with CAES using short needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence was defined as the recurrence of bleeding, prolapse and other symptoms in patients from 3 days to 24 weeks after CAES or seeking other non-surgical treatment and surgical treatment of internal hemorrhoids again within 24 weeks (except drug conservative treatment). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of anal bleeding | Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often. | 1day, 7days, 14days and 24 weeks | 
| Symptoms of prolapse | There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often. | 1day, 7days, 14days and 24 weeks | 
| Symptoms of anal pain | NRS pain digital rating scale was adopted, that is, 0-10 was used to represent different degrees of pain, 0 was painless, and 10 was severe pain. 0 painless, 1-3 mild pain (pain does not affect sleep), 4-6 moderate pain, 7-9 severe pain (inability to fall asleep or waking up during sleep), 10 severe pain. | 1day, 7days, 14days and 24 weeks | 
| EQ-5D health scale scores | Before CAES and after CAES, EQ-5D health scale scores were performed. | 24 weeks | 
| Adverse events and serious adverse events | Adverse events included bleeding, anal pain, and dyspnea.Serious adverse events include serious complications directly or indirectly related to the operation, such as death, bleeding, perforation, etc. | 1day, 7days, 14days and 24 weeks | 
| Satisfaction degree | Number of satisfied participants | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cap-assisted endoscopic sclerotherapy, Internal Hemorrhoid, Rectal Prolapse