The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

March 3, 2022 updated by: Alpaslan Şahin, Konya Meram State Hospital

Comparative Study of Band Ligation and Phlebotonic Drug Versus Only Phlebotonic Drug, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42090
        • Konya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients between the ages of 18 and 65 who apply to our hospital from Konya and neighboring provinces and accept the treatments offered, constitute the study population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.)
Procedure: 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.)

Drug: 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.)
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.)
Drug: 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemostasis rate
Time Frame: 21 days
At the end of the treatment, the proportion of patients without hemorrhoids bleeding will be calculated.
21 days
Hemorrhage stopped on the day of treatment.
Time Frame: 21 days
It will be determined that the bleeding stops on the day of treatment.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hemorrhoids X. study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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