A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

• Conditions: Quality of Life; Hemorrhoids; Indication, Unlabeled; Complication of Treatment

• Registration Number: NCT05429060
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-11
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-17
• Last Update Submitted: 2022-06-17
• Study First Posted: 2022-06-23
• Last Update Posted: 2022-06-23
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medipol University Bahcelievler Hospital; 🇹🇷 Istanbul, Bahcelievler, Turkey