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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thrombosed External Hemorrhoid

Intervention / Treatment
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* Procedure: Thrombectomy
* Procedure: Hemorrhoidectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thrombectomy<br>Patients with thrombosed external hemorrhoids undergoing thrombectomy | Procedure: Thrombectomy<br>* A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.<br>|
| Local excision/ Hemorrhoidectomy<br>Patients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy | Procedure: Hemorrhoidectomy<br>* A surgery to remove the hemorrhoid, including the blood vessels and clot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month complication rate | 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. | 6 months from operation | 
| 6-month quality of life outcomes | 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 | 6 months from operation |