Endoscopic Injection Sclerotherapy Versus Endoscopic Band Ligation for Grade I-III Internal Hemorrhoids

Prospective Multicenter Clinical Study of Flexible Endoscopic Treatment for Grade I-III Internal Hemorrhoids

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

Continuous recruitment of symptomatic internal hemorrhoid patients who visited the main center and sub centers was conducted using a stratified block randomization method, with a 1:1 random allocation to the endoscopic injection sclerotherapy group and endoscopic band ligation group for intervention. During the perioperative period, demographic characteristics, intraoperative conditions, postoperative complications and surgery related costs, length of hospital stay were recorded, and HDSS, EQ-5D-5L, EQ-VAS scores were recorded. Changes in scores were recorded during telephone follow-up at 2 weeks, 3 months, and 12 months after surgery, as well as whether the patient's symptoms improved, recurred, and satisfaction was assessed.

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.