Complication of Treatment, Hemorrhoids, Indication, Unlabeled, Quality of Life
Conditions
Brief summary
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.
Interventions
PROCEDUREHemorrhoidal 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.
Sponsors
Istanbul Medipol University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery | 1 year | 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. |
| Hemorrhoidal Disease Symptom Score at 1 year after hemorrhoidal surgery | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 1 year | 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. |
| Complications | 1 year | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactNaciye Cigdem Arslan, MD
Outcome results
None listed