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CompletedNCT04290351Updated Mar 18, 2022

The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

An observational study in Hemorrhoids, Internal, sponsored by Konya Meram State Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Konya Meram State Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
69
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Hemorrhoids, Internal

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03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's enrollment of 69 is below the median of 151 across 49 observational studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Konya Meram State Hospital is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope.

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
69 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · 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.)

    Drug: oral 450 mg diosmin+50 mg hesperidin

Interventions

  • Procedureband 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.)

  • Drugoral 450 mg diosmin+50 mg hesperidin

    Drug page: 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.)

06

What researchers measure

Primary outcomes

  1. hemostasis rate

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

    Time frame: 21 days

  2. Hemorrhage stopped on the day of treatment.

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

    Time frame: 21 days

07

Study locations

1 site
  • Konya Training and Research Hospital
    Konya, 42090, Turkey (Türkiye)
08

References and documents

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 26309351 ↗
  • Albuquerque 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 27721924 ↗
  • Schleinstein 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Nov 2021, 12 months.

Of 27 observational studies under Hemorrhoids, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2020
First posted
Feb 28, 2020
StartActual
Nov 1, 2020
Primary completionActual
Nov 1, 2021
CompletionActual
Dec 20, 2021
Last update
Mar 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04290351
Lead sponsor
Konya Meram State Hospital
Responsible party
Alpaslan Şahin (principal investigators, Konya Meram State Hospital) — Principal investigator
First posted
Feb 28, 2020
Start date
Nov 1, 2020
Primary completion
Nov 1, 2021
Completion
Dec 20, 2021
Last update
Mar 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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