NCT05429060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 11, 2022

Last Update Submit

June 17, 2022

Conditions

HemorrhoidsQuality of LifeComplication of TreatmentIndication, Unlabeled

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Recurrence

    1 year

  • Complications

    1 year

Interventions

Hemorrhoidal surgeryPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University Bahcelievler Hospital

Istanbul, Bahcelievler, 34196, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Kement M, Tekin A, Baysal H, Tosun S, Alimoglu O, Sucullu I, Civil O, Sakoglu N, Arslan NC, Tatar C, Nayci AE, Ari A, Cakir E, Kaya R, Turan I, Gulsen T, Meric S, Yavuz E, Bugdayci N, Hamad FM, Leventoglu S, Kozan R, Akpinar O, Yanar H, Yanar F, Kucuk HF, Karahan M, Kaya S, Adiguzel NC, Onder T, Abci I, Aydin AZ, Ozkan OF, Kiziltoprak N, Ozcan B, Orhan A, Canturk AO, Tan M, Bilgin Y, Cok H, Cezit A, Fersahoglu MM, Oncel M. Patient-reported outcomes after hemorrhoid surgery: early results from a prospective, nationwide, real-world, cohort study on diverse approaches. Ann Coloproctol. 2025 Dec;41(6):573-585. doi: 10.3393/ac.2025.00710.0101. Epub 2025 Dec 30.

    PMID: 41486915DERIVED

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Naciye Cigdem Arslan, MD

    Medipol University

    STUDY DIRECTOR

Central Study Contacts

Naciye Cigdem Arslan, MD

CONTACT

+905313890975cigdemarslan@hotmail.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

June 23, 2022

Study Start

June 1, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 23, 2022

Record last verified: 2022-05

Locations

TU(1)