The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

Completed

• Conditions: Hemorrhoids, Internal
• Interventions: Procedure: band ligation; Drug: oral 450 mg diosmin+50 mg hesperidin

• Registration Number: NCT04290351
• Lead Sponsor: Konya Meram State Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Study Start: 2020-11-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Band ligation and phlebotonic group	oral 450 mg diosmin+50 mg hesperidin	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 and phlebotonic group	band ligation	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.)
Only phlebotonic group	oral 450 mg diosmin+50 mg hesperidin	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.)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey