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Completed

NCT Number: NCT03903536

Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome (TEH)

The primary aim of the current study is to evaluate and compare 6-month complication rates after thrombectomy and local excision treatments.

The investigators aim to compare thrombectomy and local excision treatments in many different aspects:

* The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month). * The investigators will examine bleeding, pain, anal stricture/stenosis, infection, time until return to normal daily activity, relapse and incontinence after treatment * To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in patients. * The investigators will use the Wexner incontinence score for assessment of incontinence.

In each hospital, medical students, residents and surgeons can be involved in the study. In the following 6-month period, all collaborators will be collecting the data of the patients who have been operated for external hemorrhoids via the thrombectomy or local excision procedures.

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Key information

Conditions

Thrombosed External Hemorrhoid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are diagnosis with thrombosed external hemorrhoids.
  • Providing a written informed consent form for the surgeries and for participation in the study
  • Patients aged 18 years and over should be included

Exclusion criteria

  • Patients younger than 18 years of age,
  • Pregnancy
  • Patients who have a history of cancer or inflammatory bowel disease(IBD)
  • Patients who have a history of anorectal fistula
  • Patients with metabolic disorders
  • Patients with alcohol or substance addiction
  • Patients who refuse to participate in the study and do not provide informed consent
  • Patients who, at any stage of the study, indicate that they want to leave the study.

Treatment and study plan

Thrombectomy

Procedure

A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.

Hemorrhoidectomy

Procedure

A surgery to remove the hemorrhoid, including the blood vessels and clot.

Primary outcomes

  1. 6-month complication rate

    Time frame: 6 months from operation

    • The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month).
    • The investigators will examine anal bleeding(exist or not), pain(exist or not), anal stricture/stenosis(exist or not, its severity), infection(exist or not), time until return to normal daily activity, relapse and incontinence after treatment.
    • The investigators will use the Wexner incontinence score for assessment of incontinence.
    • The investigators will measure the internal diameter of anal canal for the assessment of anal stenosis and its severity. When the internal diameter of anal canal is less than 0.5 cm, it is severe stenosis and when the diameter is 0.5-1 cm stenosis is moderate and 1-1.5 cm diameter is known as mild stenosis.

  2. 6-month quality of life outcomes

    Time frame: 6 months from operation

    Quality of life outcomes within 6 months of surgical procedure. To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

    Sections:

    • Vitality
    • Physical functioning
    • Bodily pain
    • General health perceptions
    • Physical role functioning
    • Emotional role functioning
    • Social role functioning
    • Mental health

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Treatment of Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome: A Multi-Centre, International, Prospective Cohort Study

Acronym: TEH

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 4, 2019
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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