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OpenTrials
Completed

NCT Number: NCT04290351

The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

band ligation

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

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.)

Primary outcomes

  1. hemostasis rate

    Time frame: 21 days

    At the end of the treatment, the proportion of patients without hemorrhoids bleeding will be calculated.

  2. Hemorrhage stopped on the day of treatment.

    Time frame: 21 days

    It will be determined that the bleeding stops on the day of treatment.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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