A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

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

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 Overview

• Status: Recruiting
• Conditions: Quality of Life; Hemorrhoids; Complication of Treatment; Indication, Unlabeled
• Intervention / Treatment: Procedure: Hemorrhoidal surgery

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Naciye Cigdem Arslan, MD; Phone Number: +905313890975; Email: cigdemarslan@hotmail.it

Study Locations

• Turkey
  • Bahcelievler
    • Istanbul, Bahcelievler, Turkey, 34196
      • Recruiting
      • Medipol University Bahcelievler Hospital
      • Contact: Osman Civil, MD; Phone Number: +905058334286; Email: dr.ocivil@hotmail.com
      • Sub-Investigator: Nuri Okkabaz, MD
      • Contact: Nevin Sakoglu, MD; Phone Number: +905333741297; Email: nsakoglu@medipol.edu.tr
      • Principal Investigator: Naciye Cigdem Arslan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults who underwent any interventional treatment other than medical therapy under local and/or general anesthesia will be eligible.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Naciye Cigdem Arslan, MD, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: E-10840098-772.02-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No