Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

April 1, 2024 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • Fmt-Dt-N-27/1350
        • Contact:
          • Faming Zhang, PhD,MD
        • Principal Investigator:
          • Faming Zhang, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 24 weeks
Recurrence rate defined as the proportion of patients with recurrent hemorrhoids at 24 weeks post-CAES, as derived from patients' self-reported answer. Patients will be considered to have recurrent hemorrhoids when any of the following are recorded: (1)"Unchanged or worse compared with before starting treatment" at 24th week as reported by the patient, or (2) seeking repeat CAES treatment, alternative non-surgical/surgical treatments for internal hemorrhoids within 24weeks (except medication treatment), or (3) presence of any symptoms or events that strongly indicated recurrent hemorrhoids among patients not meeting (1) or (2).
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of anal bleeding
Time Frame: 1day, 7days, 14days and 24 weeks
Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.
1day, 7days, 14days and 24 weeks
Symptoms of prolapse
Time Frame: 1day, 7days, 14days and 24 weeks
There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.
1day, 7days, 14days and 24 weeks
Symptoms of anal pain
Time Frame: 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.
1day, 7days, 14days and 24 weeks
EQ-5D health scale scores
Time Frame: 24 weeks
Before CAES and after CAES, EQ-5D health scale scores were performed.
24 weeks
Adverse events and serious adverse events
Time Frame: 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.
1day, 7days, 14days and 24 weeks
Satisfaction degree
Time Frame: 24 weeks
Number of satisfied participants
24 weeks
Symptom severity score
Time Frame: 1day and 24 weeks
five questions about hemorrhoidal symptoms (anal pain, prolapse, itching, soiling, and blood loss) will be self-assessed by patients by answering how often each symptom was encountered (never, sometimes, weekly, or daily). The score is the sum of the points from all five questions, ranging from 0 to 15 points, where an increase in number is an increase in symptom.
1day and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, MD,PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2019

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 27, 2025

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAES-CN-190318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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