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CAES 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: NCT04169152
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Brief Summary:
Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.

Condition or disease Intervention/treatment
Internal Hemorrhoid Rectal Prolapse Procedure: Cap-assisted endoscopic sclerotherapy

Detailed Description:
CAES is an innovative endoscopic sclerotherapy procedure which is different from traditional method. Firstly, the cap added to the front of colonoscope can fully expose the operating field. Secondly, before or during the opportunity of CAES, endoscopist can perform endoscopic differentiation diagnosis (such as tumors, inflammatory bowel disease and others induced hematochezia), endoscopic therapy within lower-gut based on the same colon preparation, thus saving patients' medical cost, physical and mental pain. The last but not least, specially designed length of endoscopic injection needle (eg.10-20 mm) was used in CAES could be helpful for accurately controlling the injection angle, direction, depth under direct vision and to avoid iatrogenic injury due to ectopic injection.The core value of CAES for internal hemorrhoids and rectal prolapse is to provide precise therapy, reduce the iatrogenic injuries, avoid pain during and after therapy. Our pilot studies demonstrated that CAES based on long injection needle is an effective, safe, convenient operation technique. 100% of participants underwent CAES showed sustained clinical efficacy within the 3-month follow-up, with no severe or obvious complications related to CAES. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse need to be confirmed by further large sample real world studies.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study
Estimated Study Start Date : December 30, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Internal hemorrhoids and rectal prolapse
Participants were treated with Cap-assisted endoscopic sclerotherapy (CAES).
Procedure: Cap-assisted endoscopic sclerotherapy
Cap-assisted endoscopic sclerotherapy (CAES) is an innovation technique for having advantages in accurately controlling the injection angle, direction, depth under direct vision of flexible endoscope.




Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 1st week to 24th week ]
    Recurrence defined as recurrent prolapse, bleeding and other symptoms such as anal pendant expansion, itching, dampness and others after CAES or seeking repeat CAES treatment, alternative non-surgical/surgical treatments for internal hemorrhoids or rectal prolapse (except medication treatment).


Secondary Outcome Measures :
  1. Improvement rate [ Time Frame: 1st day, 1st week, 2nd week and 24th week ]
    Bleeding, prolapse, and anal pain had resolved or remitted after CAES. Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.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.

  2. Failure rate [ Time Frame: 1st day, 1st week, 2nd week and 24th week ]
    Bleeding, prolapse, and anal pain remained the same after CAES. Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.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.

  3. Three-level EuroQol five dimensions (ED-5Q) health scale scores [ Time Frame: 24th week ]
    The ED-5Q questionnaire includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with three levels in each dimension (no/moderate/severe problem). Through the Chinese time trade-off (TTO) value table, the health status of five dimensions will be converted into a preference weight of a ED-5Q index score for further analysis.

  4. Adverse events (AEs) [ Time Frame: 1st day, 1st week, 2nd week and 24th week ]
    AEs refer to adverse medical events that occurs during or after CAES, including bleeding, anal pain, having difficulties in passing gas and defecation, infection, ulcer/bleeding in the injection points under endoscopic examination (5-7 days after CAES) and other symptoms.

  5. severe adverse events (SAEs) severe adverse events (SAEs) severe adverse events (SAEs) Severe adverse events (SAEs) [ Time Frame: 1st day, 1st week, 2nd week and 24th week ]
    SAEs include serious complications directly or indirectly related to the CAES, such as death, bleeding, perforation, infection.

  6. Participants' attitudes toward CAES [ Time Frame: 24th week ]
    The survey on the satisfaction with CAES efficacy, and the willingness to recommend CAES to others.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Grade I-III internal hemorrhoids and/or rectal prolapse
Criteria

Inclusion Criteria:

  1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
  2. Patients with bowel preparation.

Exclusion Criteria:

  1. History of anoscopic/endoscopic sclerotherapy.
  2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
  3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
  4. Inflammatory bowel disease.
  5. Full-thickness rectal prolapse through the anus.
  6. Acute diarrhea in the past 24 hours.
  7. Hypertensive with uncontrolled blood pressure.
  8. Cerebrovascular accident.
  9. Blood coagulation dysfunction.
  10. Pregnant women.
  11. Mental disorders.
  12. 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): NCT04169152


Contacts
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Contact: Faming Zhang, MD,PhD 02558509884 fzhang@njmu.edu.cn

Sponsors and Collaborators
Faming Zhang
Investigators
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Study Chair: 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: NCT04169152    
Other Study ID Numbers: CAES-CN-191111
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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