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

NCT04398823 | Unknown Phase 4

• 1 other identifier: XH-20-006
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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

Conditions

Grade/Stage I Hemorrhoids; Prolapsed Grade II Internal Haemorrhoid; Prolapsed Grade III Internal Haemorrhoid

Keywords

hemorrhoids

Outcome Measures

Primary Outcomes (2)

• the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.

  After 12 months,all the participants will receive the telephone follow-up to record their self-assessment.

  12 months

• the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.

  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.

  12 months

Secondary Outcomes (4)

• the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.

  1 day

• the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.

  3 months

• the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.

  1 week

• the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.

  3 months

Study Arms (2)

Foam sclerotherapy,FS

ACTIVE COMPARATOR

Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.

Drug: Sclerosing foam of Lauromacrogol

Liquid sclerotherapy,Ls

PLACEBO COMPARATOR

Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.

Drug: Sclersing liqiud of Lauromacrogol

Interventions

Sclerosing foam of Lauromacrogol DRUG

Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.

Foam sclerotherapy,FS

Sclersing liqiud of Lauromacrogol DRUG

Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.

Liquid sclerotherapy,Ls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Tongren Hospital,Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Construction Group Hospital: collaborator
• Shandong Maternal and Chidl Care Service Center: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• West China Fourth Hospital, Sichuan University: collaborator
• The First Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Jiangsu Provincial Second Chinese Medicine Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Luoyang Central Hospital: collaborator
• Ganzhou Fifth pepole's Hospital: collaborator
• Changzhi People's Hospital: collaborator
• Nanjing PLA General Hospital: collaborator

Study Sites (1)

Xinhua Hospital,Shangha Jiao Tong University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leiming Xu

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Yi Zhang

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Zhenzhong Deng

  Xinhua Hospital, Shanghai Jiao Tong 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Shen

CONTACT

18202159980; shenfeng01@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 21, 2020
• Study Start: May 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-04

Locations

CN (1)