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

NCT ID: NCT06649786

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Endoscopic superior rectal mucosal ligation group

The patient is treated with endoscopic superior rectal mucosal ligation

Group Type EXPERIMENTAL

Endoscopic superior rectal mucosal ligation

Intervention Type PROCEDURE

The patient takes the left side decubitus position, the endoscope is connected with 6 serial ligators, the cup of the sleeve is pointed at the upper edge of the straight anal line and the rectal mucosa is continuously aspirated under negative pressure. The mucosa enters the sleeve and sees a full-screen red sign. The sensing loop is successfully triggered, indicating that the loop is complete.

Endoscopic hemorrhoid ligation group

The patient is treated with endoscopic hemorrhoids ligation

Group Type ACTIVE_COMPARATOR

Endoscopic hemorrhoid ligation

Intervention Type PROCEDURE

The patient takes the left side decubitus position,the endoscope is connected with 6 serial ligators,the cup the sleeve is aligned with the base of the hemorrhoid (above the dentate line) for continuous negative pressure suction.The hemorrhoid enters the sleeve and sees a full-screen red sign. Turn the handle of the sleeve clockwise and feel that the loop is successfully triggered, the ligature is completed.

Interventions

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Endoscopic superior rectal mucosal ligation

The patient takes the left side decubitus position, the endoscope is connected with 6 serial ligators, the cup of the sleeve is pointed at the upper edge of the straight anal line and the rectal mucosa is continuously aspirated under negative pressure. The mucosa enters the sleeve and sees a full-screen red sign. The sensing loop is successfully triggered, indicating that the loop is complete.

Intervention Type PROCEDURE

Endoscopic hemorrhoid ligation

The patient takes the left side decubitus position,the endoscope is connected with 6 serial ligators,the cup the sleeve is aligned with the base of the hemorrhoid (above the dentate line) for continuous negative pressure suction.The hemorrhoid enters the sleeve and sees a full-screen red sign. Turn the handle of the sleeve clockwise and feel that the loop is successfully triggered, the ligature is completed.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Na Zu

Role: CONTACT

19105496203

Other Identifiers

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QYFYEC2024-137

Identifier Type: -

Identifier Source: org_study_id

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