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A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05429060
Collaborator
(none)
2,000
Enrollment
1
Location
24
Anticipated Duration (Months)
83.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hemorrhoidal surgery

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medipol University Bahcelievler Hospital Istanbul Bahcelievler Turkey 34196

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

  • Study Director: Naciye Cigdem Arslan, MD, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05429060
Other Study ID Numbers:
  • E-10840098-772.02-109
First Posted:
Jun 23, 2022
Last Update Posted:
Jun 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemorrhoids

Study Results

No Results Posted as of Jun 23, 2022