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

"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

Study Overview

• Status: Unknown
• Conditions: Grade/Stage I Hemorrhoids; Prolapsed Grade II Internal Haemorrhoid; Prolapsed Grade III Internal Haemorrhoid
• Intervention / Treatment: Drug: Sclerosing foam of Lauromacrogol; Drug: Sclersing liqiud of Lauromacrogol

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Feng Shen; Phone Number: 18202159980; Email: shenfeng01@xinhuamed.com.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Xinhua Hospital,Shangha Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.	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.	1 day
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.	After 3 months,all the participants will receive the telephone follow-up to record their self-assessment.	3 months
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.	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.	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.	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.	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: hemorrhoids
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: XH-20-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No