Hemorrhoids, InternalNCT04290351
The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.
An observational study of Hemorrhoids, Internal, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids, Internal
- What is being tested?
- band ligation and oral 450 mg diosmin+50 mg hesperidin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhoids, Internal
- Being tested
- band ligation, oral 450 mg diosmin+50 mg hesperidin
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
band ligationProcedure or surgery
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 hesperidinDrug
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Procedure: band ligation; Drug: oral 450 mg diosmin+50 mg hesperidin | |
| 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.) Receives: Drug: oral 450 mg diosmin+50 mg hesperidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemostasis rate
At the end of the treatment, the proportion of patients without hemorrhoids bleeding will be calculated.
Measured: 21 days
Hemorrhage stopped on the day of treatment.
It will be determined that the bleeding stops on the day of treatment.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Nov 2020
- Primary completion1 Nov 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoids, InternalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290351
- Sponsor's protocol ID
- hemorrhoids X. study
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist's view. World J Gastroenterol. 2015 Aug 21;21(31):9245-52. doi: 10.3748/wjg.v21.i31.9245.
PubMed 26309351Albuquerque A. Rubber band ligation of hemorrhoids: A guide for complications. World J Gastrointest Surg. 2016 Sep 27;8(9):614-620. doi: 10.4240/wjgs.v8.i9.614.
PubMed 27721924Schleinstein HP, Averbach M, Averbach P, Correa PAFP, Popoutchi P, Rossini LGB. ENDOSCOPIC BAND LIGATION FOR THE TREATMENT OF HEMORRHOIDAL DISEASE. Arq Gastroenterol. 2019 May 20;56(1):22-27. doi: 10.1590/S0004-2803.201900000-15.
PubMed 31141063
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Band Ligation and Phlebotonic Drug Versus Only Phlebotonic Drug, in Bleeding Internal Hemorrhoids.
- ClinicalTrials.gov ID
- NCT04290351
- Acronym / sponsor ID
- hemorrhoids X. study
- Conditions
- Hemorrhoids, Internal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Band ligation and phlebotonic group | – | Procedure: band ligation, Drug: oral 450 mg diosmin+50 mg hesperidinPatients 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 | – | Drug: oral 450 mg diosmin+50 mg hesperidinPatients 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.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope.
Key exclusion criteria (8 listed)
- Patients under 18 years old
- Patients over 65 years old
- Pregnant
- Chronic liver patients
- Those with bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| band ligationRubber 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.) | Procedure or surgery | Band ligation and phlebotonic group |
| oral 450 mg diosmin+50 mg hesperidin450 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.) | Drug | Band ligation and phlebotonic group, Only phlebotonic group |
Primary outcome
hemostasis rate
Time frame: 21 days
At the end of the treatment, the proportion of patients without hemorrhoids bleeding will be calculated.
Hemorrhage stopped on the day of treatment.
Time frame: 21 days
It will be determined that the bleeding stops on the day of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 26309351Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist's view. World J Gastroenterol. 2015 Aug 21;21(31):9245-52. doi: 10.3748/wjg.v21.i31.9245.
- Background: PubMed 27721924Albuquerque A. Rubber band ligation of hemorrhoids: A guide for complications. World J Gastrointest Surg. 2016 Sep 27;8(9):614-620. doi: 10.4240/wjgs.v8.i9.614.
- Background: PubMed 31141063Schleinstein HP, Averbach M, Averbach P, Correa PAFP, Popoutchi P, Rossini LGB. ENDOSCOPIC BAND LIGATION FOR THE TREATMENT OF HEMORRHOIDAL DISEASE. Arq Gastroenterol. 2019 May 20;56(1):22-27. doi: 10.1590/S0004-2803.201900000-15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids, Internal, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemostasis rate (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290351, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.