Comparison of the Clinical Efficacy and Safety of Endoscopic Superior Rectal Mucosal Ligation and Hemorrhoids Ligation

Qingdao University

Status: Not yet enrolling

Conditions: Hemorrhoids

Treatments: Procedure: Endoscopic hemorrhoid ligation; Procedure: Endoscopic superior rectal mucosal ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT06649786

QYFYEC2024-137

Details and patient eligibility

About

Endoscopic superior rectal mucosal ligation and hemorrhoids ligation are two types of endoscopic ligation, The aim of this study is to compare the clinical efficacy and safety of these two approaches.If you accept this study,you need to provide case information before the operation, complete the endoscopic treatment according to the routine colonoscopy procedure, and follow-up survey after the operation.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. According to the Goligher classification in the Chinese guidelines for the diagnosis and treatment of hemorrhoids (2020) , patients who are diagnosed with grade II-III internal hemorrhoids .
2. Patients who voluntarily participate and sign the informed consent form.

Exclusion criteria

1. patients who had severe heart, liver, and kidney disease.
2. patients who had severe immune deficiency.
3. patient's general condition is too poor to tolerate endoscopic therapy.
4. patients had a history of pelvic chemoradiotherapy.
5. patients had severe infection or inflammatory lesion in the rectum or anal canal,or the rectum or anal canal had undergone surgery.
6. patient is a pregnant woman.
7. patients who disagree with endoscopic treatment and are concerned about the possible risks refused to sign the informed consent form.
8. the follow-up time is insufficient and the clinical data were incomplete.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Endoscopic superior rectal mucosal ligation group

Experimental group

Description:

The patient is treated with endoscopic superior rectal mucosal ligation

Treatment:

Procedure: Endoscopic superior rectal mucosal ligation

Endoscopic hemorrhoid ligation group

Active Comparator group

Description:

The patient is treated with endoscopic hemorrhoids ligation

Treatment:

Procedure: Endoscopic hemorrhoid ligation