NCT04290351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 25, 2020

Last Update Submit

March 3, 2022

Conditions

Hemorrhoids, Internal

Outcome Measures

Primary Outcomes (2)

  • hemostasis rate

    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.

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

    21 days

Study Arms (2)

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 ligationDrug: 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

band ligationPROCEDURE

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.)

Band ligation and phlebotonic group
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.)

Band ligation and phlebotonic groupOnly phlebotonic group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 26309351BACKGROUND

  • 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.

    PMID: 27721924BACKGROUND

  • 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.

    PMID: 31141063BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigators

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 20, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

TU(1)