The Two Treatment Methods Compared the Sclerosing Agent Injection and the Rubber Wrapping

Not Applicable

• Conditions: Hemorrhoid Bleeding; Hemorrhoid Pain; Hemorrhoid; Hemorrhoids; Hemorrhoids Internal; Hemorrhoid Prolapse
• Interventions: Other: Endoscopic injection sclerotherapy; Other: Endoscopic Band Ligation

• Registration Number: NCT05089500
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores

Detailed Description

From November 2021 to July 2022, patients with internal hemorrhoids seeking treatment were enrolled according to the following criteria:

1. Age 18 to 75, men and women;

2. Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy;

3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.

Exclusion criteria are as follows:

1. age \<18 or\> 75;

2. External hemorrhoids or mixed hemorrhoids;

3. Ⅳ degree of hemorrhoid

4. Unsymptomatic internal hemorrhoids;

5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection;

6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;

7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.;

8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;

9. Women in pregnancy or puerperium;

10. Sclerotic with allergy patient , such as polycininol, etc;

11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;

12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Study Start: 2021-11-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 984

Inclusion Criteria

1. Age 18 to 75, men and women;
2. Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy;
3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.

Exclusion Criteria

1. Age <18 or age> 75;
2. External hemorrhoids or mixed hemorrhoids;
3. degree Ⅳ internal hemorrhoids
4. Unsymptomatic internal hemorrhoids
5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection；
6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;
7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.;
8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;
9. Women in pregnancy or puerperium;
10. Hardening agent allergy patients, such as polycininol, etc;
11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;
12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic injection sclerotherapy	Endoscopic injection sclerotherapy	-
Endoscopic Band Ligation	Endoscopic Band Ligation	-

Primary Outcome Measures

Name	Time	Method
recurernce rate	12 months	After treatment, the recurrence of internal hemorrhoids symptoms (based on Goligher score and HDSS symptom score)

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction survey	12 months	Patient satisfaction evaluation of the treatment method
Postoperative complications and adverse events	12 months	Patients from complications and serious adverse events following intervention
Surgical costs	12 months	Cost of treatment
Health-related QIL score	12 months	Assessment of patient quality of life after surgery

Trial Locations

Locations (2)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Mingkai Chen; 🇨🇳 Wuhan, Hubei, China