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Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917056
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 24, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 27, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 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 :
  1. 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.

  2. 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.

  3. 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.

  4. EQ-5D health scale scores [ Time Frame: 24 weeks ]
    Before CAES and after CAES, EQ-5D health scale scores were performed.

  5. 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.

  6. Satisfaction degree [ Time Frame: 24 weeks ]
    Number of satisfied participants



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917056


Contacts
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Contact: Faming Zhang, MD,PhD 86-25-58509883 fzhang@njmu.edu.cn

Locations
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China, Jiangsu
Fmt-Dt-N-27/1350 Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, PhD,MD         
Principal Investigator: Faming Zhang, MD,PhD         
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Principal Investigator: Faming Zhang, MD,PhD The Second Hospital of Nanjing Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Faming Zhang, Professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03917056    
Other Study ID Numbers: CAES-CN-190318
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Cap-assisted endoscopic sclerotherapy
Internal Hemorrhoid
Rectal Prolapse
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Prolapse
Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Pelvic Organ Prolapse