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A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

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: NCT04398823
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborators:
Tongren Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai Construction Group Hospital
Shandong Maternal and Chidl Care Service Center
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
West China Forth University Hospital,Sichuan University
The First Hospital of Anhui Medical University
The First Affiliated Hospital of Zhengzhou University
Jiangsu Provincial Second Chinese Medicine Hospital
Anhui Provincial Hospital
Luoyang Central Hospital
Ganzhou Fifth pepole's Hospital
Changzhi People's Hospital
Nanjing PLA General Hospital
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
"Internal hemorrhoid" affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in

Condition or disease Intervention/treatment Phase
Grade/Stage I Hemorrhoids Prolapsed Grade II Internal Haemorrhoid Prolapsed Grade III Internal Haemorrhoid Drug: Sclerosing foam of Lauromacrogol Drug: Sclersing liqiud of Lauromacrogol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Polidocanol

Arm Intervention/treatment
Active Comparator: Foam sclerotherapy,FS
Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.
Drug: Sclerosing foam of Lauromacrogol
Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.

Placebo Comparator: Liquid sclerotherapy,Ls
Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.
Drug: Sclersing liqiud of Lauromacrogol
Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.




Primary Outcome Measures :
  1. the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment. [ Time Frame: 12 months ]
    After 12 months,all the participants will receive the telephone follow-up to record their self-assessment.

  2. the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy. [ Time Frame: 12 months ]
    after 12 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy.


Secondary Outcome Measures :
  1. the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment. [ Time Frame: 1 day ]
    one day after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus.

  2. the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment. [ Time Frame: 3 months ]
    After 3 months,all the participants will receive the telephone follow-up to record their self-assessment.

  3. the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment. [ Time Frame: 1 week ]
    one week after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus.

  4. the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy. [ Time Frame: 3 months ]
    after 3 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People are willing to sign the informed consent form of this trial.
  • People(aged 18 to 70 years) with clinical symptoms such as bleedingprolapse and so on have been diagnosed with grade I, grade II and grade III internal hemorrhoids by colonic epdoscopy;
  • People can follow short-term (3 month) and long-term (12 month) visit plans;
  • Describe symptoms objectively and actively complete the evaluation scale;
  • No allergic diseases and allergy to sclerosing drugs;
  • Non-lactating and pregnant women: patients without pregnancy plan (including the men) in 1 month after the test;
  • Did not participate in any drug trials (including this trial drug) within 3 months before the trial;
  • People with long-term use of anticoagulant drugs (such as aspirin, clopidogrel, etc.) need to be stopped for 5-7 day

Exclusion Criteria:

  • People with severe insufficiency of heart, brain, lung and other organs, leading to inability to tolerate endoscopic treatment;
  • People with drug allergies or abnormal blood coagulation function;
  • People suffering from or combined with digestive tract diseases,such as the colon malignancyulcerative colitis or Crohn's diseaseacute diarrheaacute thrombotic internal hemorrhoids with painanal fistulaanal fissurefecal incontinence
  • Men with history of severe prostate hypertrop;
  • People with any reasons that the researchers believe can not be selected

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): NCT04398823


Contacts
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Contact: Feng Shen 18202159980 shenfeng01@xinhuamed.com.cn

Locations
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China
Xinhua Hospital,Shangha Jiao Tong University Recruiting
Shanghai, China
Contact: Feng Shen         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Tongren Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai Construction Group Hospital
Shandong Maternal and Chidl Care Service Center
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
West China Forth University Hospital,Sichuan University
The First Hospital of Anhui Medical University
The First Affiliated Hospital of Zhengzhou University
Jiangsu Provincial Second Chinese Medicine Hospital
Anhui Provincial Hospital
Luoyang Central Hospital
Ganzhou Fifth pepole's Hospital
Changzhi People's Hospital
Nanjing PLA General Hospital
Investigators
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Study Chair: Leiming Xu Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Principal Investigator: Yi Zhang Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Principal Investigator: Zhenzhong Deng Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Principal Investigator: Haixia Peng Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine
Principal Investigator: Hui Pan Shanghai Construction Group Hospital
Principal Investigator: Fengyu Gao Shandong Maternal and Child Health Center affiliated to Shandong University
Principal Investigator: Hao Zhang BaoShan People's Hospital
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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04398823    
Other Study ID Numbers: XH-20-006
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: April 2020

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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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
hemorrhoids
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions