A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

Istanbul Medipol University Hospital2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Hemorrhoids Quality of Life Complication of Treatment Indication, Unlabeled

Interventions

Hemorrhoidal surgeryPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Medipol University Bahcelievler Hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 year

Central Contacts

Naciye Cigdem Arslan, MD

CONTACT

+905313890975 cigdemarslan@hotmail.it

Data from ClinicalTrials.gov

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