A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429060
• Other study ID #: E-10840098-772.02-109
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2022
• Source: Istanbul Medipol University Hospital
• Contact: Naciye Cigdem Arslan, MD
• Phone: +905313890975
• Email: cigdemarslan[@]hotmail.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Turkey	Medipol University Bahcelievler Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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