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Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

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ClinicalTrials.gov Identifier: NCT03917056
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 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:
CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. 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. 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. Participants with internal hemorrhoids and rectal prolapse who underwent CAES 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
Estimated Study Start Date : April 12, 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. The effective rate [ Time Frame: 12 weeks ]
    When the internal hemorrhoid and/or rectal prolapse size had decreased on endoscopy or prolapse and hemorrhage after defecation had resolved, the treatment was judged to be effective.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 weeks ]
    Number of participants with treatment-related adverse events

  2. Satisfaction degree [ Time Frame: 12 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:
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Responsible Party: Faming Zhang, Professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03917056     History of Changes
Other Study ID Numbers: CAES-CN-190318
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 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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Prolapse
Hemorrhoids
Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Pelvic Organ Prolapse