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

Phase 4

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

• Registration Number: NCT04398823
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-05-09
• Study Start: 2020-05-15
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid sclerotherapy,Ls	Sclersing liqiud of Lauromacrogol	Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.
Foam sclerotherapy,FS	Sclerosing foam of Lauromacrogol	Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.

Primary Outcome Measures

Name	Time	Method
the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.	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.
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.	12 months	After 12 months,all the participants will receive the telephone follow-up to record their self-assessment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xinhua Hospital,Shangha Jiao Tong University; 🇨🇳 Shanghai, China