A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

Study Overview
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Brief Summary
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This study aims to evaluate the effect of surgical treatments on the quality of life in hemorrhoidal disease. All available treatment methods will be included in this 1-year cohort which is going to collect data from a big metropol.

Official Title
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A Prospective Assessment of Surgical Treatments in Hemorrhoidal Disease: Real-life Practice and Early Outcome in Terms of Patient-reported Symptoms and Quality of Life

Conditions
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Hemorrhoids, Quality of Life, Complication of Treatment, Indication, Unlabeled

Intervention / Treatment
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* Procedure: Hemorrhoidal surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical interventions under local and/or general anesthesia Elective or emergency interventions (including thrombectomy) Surgical interventions in operation room or office Any kind of excision, sclerotherapy, ligation, suturation, ablation, mucopexy Exclusion Criteria: Any accompanying perianal disease (anal fistula, anal fissure, perianal abscess, anal condyloma extending into the anal canal) Previous surgery for hemorrhoids (any intervention other than medical treatment) Previous perianal surgery (internal sphincterotomy, fistula surgery) Pelvic and/or perineal radiotherapy Previous obstetric or perianal injury and/or sphincter repair Previous rectal surgery (distal colectomy for benign or malignant etiology)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hemorrhoidal surgery|All surgical interventions under general or local anesthesia, either in the office or operation room, including any type of injection, excision, ligation, ablation, mucopexy and suturation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery | Changes in quality of life from baseline at 1 year in terms of Short Health Scale (SHS) specific to hemorrhoidal disease (HD) will be reported for each surgical treatment. The SHS-HD scores will be recorded preoperatively, at 1 week, 6 weeks, and 12 months. | 1 year | 
| Hemorrhoidal Disease Symptom Score at 1 year after hemorrhoidal surgery | Changes in symptoms from baseline at 1 year will be reported for each surgical treatment. Hemorrhoidal Disease Symptom Score (HDSS) described by Nyström based on 5 cardinal symptoms (pain, itching, bleeding, soiling, and prolapse) will be recorded preoperatively, at 1 week, 6 weeks, and 12 months. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Determining recurrence rate at 1 year for each treatment. Relapse of patient-reported symptoms (pain, itching, bleeding, soiling, and prolapse) will be recorded at 1 year. | 1 year | 
| Complications | Determining early and late complications for each treatment. Early complications (abscess, urinary retention) will be assessed at 6 weeks. Late complications (incontinence, anal stenosis) will be assessed at 12 months. | 1 year |