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The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

Comparative Study of Band Ligation and Phlebotonic Drug Versus Only Phlebotonic Drug, in Bleeding Internal Hemorrhoids.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04290351
Enrollment
69
Registered
2020-02-28
Start date
2020-11-01
Completion date
2021-12-20
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids, Internal

Brief summary

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

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.

Interventions

PROCEDUREband 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.)

DRUGoral 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.)

Sponsors

Konya Meram State Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
hemostasis rate21 daysAt the end of the treatment, the proportion of patients without hemorrhoids bleeding will be calculated.
Hemorrhage stopped on the day of treatment.21 daysIt will be determined that the bleeding stops on the day of treatment.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026