Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids

NCT ID: NCT06250140

Last Updated: 2024-02-08

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

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-01

Brief Summary

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2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids

2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids

Detailed Description

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Conditions

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Internal Hemorrhoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Internal hemorrhoid ligation group

Endoscopic internal hemorrhoid ligation

Tie up device

Intervention Type DEVICE

The recurrence rate of internal hemorrhoids in different treatment methods

Hemorrhoids injection group

Endoscopic hemorrhoid injection was performed

Tie up device

Intervention Type DEVICE

The recurrence rate of internal hemorrhoids in different treatment methods

Internal hemorrhoids combined treatment group

Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection

Tie up device

Intervention Type DEVICE

The recurrence rate of internal hemorrhoids in different treatment methods

Interventions

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Tie up device

The recurrence rate of internal hemorrhoids in different treatment methods

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Age ≥18 years old, both sexes

2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids

3\. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed

Exclusion Criteria

* 1\. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III

Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.

2\. Patients with a history of allergy to narcotic drugs

3\. Patients who were deemed by the investigator to be ineligible for participation in the trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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964 hospital of joint Logistics Support Force

UNKNOWN

Sponsor Role collaborator

The Chinese people's liberation army army medical center

UNKNOWN

Sponsor Role collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ying Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ying Zhu Ying Zhu, Professor

Role: CONTACT

+86 13384662039 ext. Y

Zheng Zewei Zewei Zheng, Professor

Role: CONTACT

+86 23360060 ext. Zw

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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ShenzhenH

Identifier Type: -

Identifier Source: org_study_id

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