The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

NCT ID: NCT04290351

Last Updated: 2022-03-18

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

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-20

Brief Summary

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In this study, the researchers planned to compare the treatment results of patients undergoing rubber band ligation in addition to drug therapy in hemorrhagic internal hemorrhoids patients and those treated only with anti-hemorrhoidal drugs.

Detailed Description

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Introduction: Band ligation is one of the most frequently used methods in the treatment of hemorrhagic internal hemorrhoidal disease. Also, phlebotonic use and surgical excision options are available as an anti-hemorrhoidal drug in the treatment of the disease. Many studies have shown that these methods are safe to use. Band ligation is used quite often in our clinic. Whether or not band ligation is performed, these patients are prescribed phlebotonics as an anti-hemorrhoidal drug.

Purpose: In this study, investigators aimed to investigate the benefit of adding rubber band ligation to treatment in hemorrhagic internal hemorrhoidal disease treated with the anti hemorrhoidal drug.

Method: The study was planned prospectively and observationally. Patients are not assigned to groups by the researcher. The researcher cannot interfere with the treatment method given to the patient. The method of treatment is the method approved by the patient's doctor.

Patients diagnosed with internal hemorrhoids will be examined in a group of patients who are prescribed anti-hemorrhoidal drugs and rubber band ligation in the context of routine treatment.

In the other group, again, in the form of routine treatment, patients who are not given rubber band ligation and who are given only anti-hemorrhoidal drugs will be examined.

Group 1: Patients who have been prescribed 450 mg diosmin + 50 mg hesperidin as an anti-hemorrhoidal drug and rubber band ligation will be included in this group.

Group 2: Patients who have been prescribed only 450 mg of diosmin + 50 mg of hesperidin as treatment, without rubber band ligation will be included in this group.

Patients will undergo a control examination in the 21 days after treatment.

* Whether the bleeding continues?
* Which bleeding day stopped?
* The comfort of the anal area will be evaluated
* Did the side effect develop?
* Did any complications occur? The above information will be entered into the SPSS program, and statistical analysis will be done.

Conditions

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Hemorrhoids, Internal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Band ligation and phlebotonic group

Patients with rubber band ligation and the prescribed anti hemorrhoidal drug will be examined in this group.

(Note: The researcher has no contribution or intervention to the treatment method.)

band ligation

Intervention Type PROCEDURE

Rubber band ligation will be applied to patients, and then phlebotonic will be prescribed.

(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)

oral 450 mg diosmin+50 mg hesperidin

Intervention Type DRUG

450 mg diosmin + 50 mg hesperidin will be prescribed to patients undergoing band ligation.

(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)

Only phlebotonic group

Patients who are prescribed the only 450mg of diosmin + 50mg of hesperidin as a treatment for bleeding internal hemorrhoids will be examined in this group.

(Note: The researcher has no contribution or intervention to the treatment method.)

oral 450 mg diosmin+50 mg hesperidin

Intervention Type DRUG

450 mg diosmin + 50 mg hesperidin will be prescribed to patients undergoing band ligation.

(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)

Interventions

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band ligation

Rubber band ligation will be applied to patients, and then phlebotonic will be prescribed.

(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)

Intervention Type PROCEDURE

oral 450 mg diosmin+50 mg hesperidin

450 mg diosmin + 50 mg hesperidin will be prescribed to patients undergoing band ligation.

(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope.

Exclusion Criteria

* Patients under 18 years old
* Patients over 65 years old
* Pregnant
* Chronic liver patients
* Those with bleeding disorders
* Patients taking anti-coagulants and anti-aggregates
* Patients with colorectal cancer.
* Those who have had hemorrhoid surgery before
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alpaslan Şahin

principal investigators

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist's view. World J Gastroenterol. 2015 Aug 21;21(31):9245-52. doi: 10.3748/wjg.v21.i31.9245.

Reference Type BACKGROUND
PMID: 26309351 (View on PubMed)

Albuquerque A. Rubber band ligation of hemorrhoids: A guide for complications. World J Gastrointest Surg. 2016 Sep 27;8(9):614-620. doi: 10.4240/wjgs.v8.i9.614.

Reference Type BACKGROUND
PMID: 27721924 (View on PubMed)

Schleinstein HP, Averbach M, Averbach P, Correa PAFP, Popoutchi P, Rossini LGB. ENDOSCOPIC BAND LIGATION FOR THE TREATMENT OF HEMORRHOIDAL DISEASE. Arq Gastroenterol. 2019 May 20;56(1):22-27. doi: 10.1590/S0004-2803.201900000-15.

Reference Type BACKGROUND
PMID: 31141063 (View on PubMed)

Other Identifiers

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hemorrhoids X. study

Identifier Type: -

Identifier Source: org_study_id

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