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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Sclerosing foam of Lauromacrogol

Sclersing liqiud of Lauromacrogol

About this trial

This is an interventional treatment trial for Grade/Stage I Hemorrhoids focused on measuring hemorrhoids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xinhua Hospital,Shangha Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Foam sclerotherapy,FS

Liquid sclerotherapy,Ls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT04398823

First Posted

May 9, 2020

Last Updated

May 18, 2020

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

1. Study Identification

Unique Protocol Identification Number

NCT04398823

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2020 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

hemorrhoids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Foam sclerotherapy,FS

Arm Type

Active Comparator

Arm Description

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

Arm Title

Liquid sclerotherapy,Ls

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sclerosing foam of Lauromacrogol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sclersing liqiud of Lauromacrogol

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

Title

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

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

1 day

Title

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

Description

After 3 months,all the participants will receive the telephone follow-up to record their self-assessment.

Time Frame

3 months

Title

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

Description

Time Frame

1 week

Title

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

Description

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.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Feng Shen

Phone

18202159980

shenfeng01@xinhuamed.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leiming Xu

Organizational Affiliation

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yi Zhang

Organizational Affiliation

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhenzhong Deng

Organizational Affiliation

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Haixia Peng

Organizational Affiliation

Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hui Pan

Organizational Affiliation

Shanghai Construction Group Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fengyu Gao

Organizational Affiliation

Shandong Maternal and Child Health Center affiliated to Shandong University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hao Zhang

Organizational Affiliation

BaoShan People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xinhua Hospital,Shangha Jiao Tong University

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng Shen

12. IPD Sharing Statement

Learn more about this trial

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

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