Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

Sponsor

The Second Hospital of Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03917056

Collaborator

(none)

1,000

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

30.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Internal Hemorrhoid Rectal Prolapse	Procedure: Cap-assisted endoscopic sclerotherapy using long needle Procedure: Cap-assisted endoscopic sclerotherapy using short needle	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 24, 2019

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long needle group Participants were treated with CAES using long needle.	Procedure: Cap-assisted endoscopic sclerotherapy using long needle Participants were treated with CAES using long needle.
Experimental: Short needle group Participants were treated with CAES using short needle.	Procedure: Cap-assisted endoscopic sclerotherapy using short needle Participants were treated with CAES using short needle.

Arm

Intervention/Treatment

Experimental: Long needle group

Participants were treated with CAES using long needle.

Procedure: Cap-assisted endoscopic sclerotherapy using long needle

Participants were treated with CAES using long needle.

Experimental: Short needle group

Participants were treated with CAES using short needle.

Procedure: Cap-assisted endoscopic sclerotherapy using short needle

Participants were treated with CAES using short needle.

Outcome Measures

Primary Outcome Measures

Recurrence rate [24 weeks]
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).

Secondary Outcome Measures

Symptoms of anal bleeding [1day, 7days, 14days and 24 weeks]
Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.
Symptoms of prolapse [1day, 7days, 14days and 24 weeks]
There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.
Symptoms of anal pain [1day, 7days, 14days and 24 weeks]
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.
EQ-5D health scale scores [24 weeks]
Before CAES and after CAES, EQ-5D health scale scores were performed.
Adverse events and serious adverse events [1day, 7days, 14days and 24 weeks]
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.
Satisfaction degree [24 weeks]
Number of satisfied participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.