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The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290351
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Alpaslan Şahin, Konya Training and Research 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.

Condition or disease Intervention/treatment
Hemorrhoids, Internal Procedure: band ligation Drug: oral 450 mg diosmin+50 mg hesperidin

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.

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Study Type : Observational
Estimated Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Study of Band Ligation and Phlebotonic Drug Versus Only Phlebotonic Drug, in Bleeding Internal Hemorrhoids.
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemorrhoids

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

Patients will only be given anti-hemorrhoidal drugs (450 mg diosmin + 50 mg hesperidin only).

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





Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290351


Contacts
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Contact: Alpaslan ŞAHİN, MD +905052955095 drasahin@gmail.com
Contact: Gürcan ŞİMŞEK, MD +903322210000 ext 7208 drgurcansimsek@gmail.com

Locations
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Turkey
Konya Training and Research Hospital Recruiting
Konya, Turkey, 42090
Contact: Alpaslan Şahin, MD    +905052955095    drasahin@gmail.com   
Contact: Gürcan Şimşek, MD    +903322210000 ext 7208    drgurcansimsek@gmail.com   
Sub-Investigator: Kemal ARSLAN, MD         
Sponsors and Collaborators
Konya Training and Research Hospital

Publications:
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Responsible Party: Alpaslan Şahin, principal investigators, Konya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04290351    
Other Study ID Numbers: hemorrhoids X. study
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases