HemorrhoidsNCT05429060
A Prospective Evaluation of Hemorrhoidal Surgery Outcome in Istanbul
An observational study of Hemorrhoids and Quality of Life, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Quality of Life, Complication of Treatment
- What is being tested?
- Hemorrhoidal surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 31 May 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults who underwent any interventional treatment other than medical therapy under local and/or general anesthesia will be eligible.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol University Bahcelievler Hospital
Istanbul, Bahcelievler, 34196
Osman Civil, MD, +905058334286, dr.ocivil@hotmail.com
Nevin Sakoglu, MD, +905333741297, nsakoglu@medipol.edu.tr
About this study
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
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.
- Being tested
- Hemorrhoidal surgery
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoidal surgeryProcedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jun 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naciye Cigdem Arslan, MD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429060
- Sponsor's protocol ID
- E-10840098-772.02-109
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41486915
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05429060
- Acronym / sponsor ID
- E-10840098-772.02-109
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults who underwent any interventional treatment other than medical therapy under local and/or general anesthesia will be eligible.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemorrhoidal surgeryAll 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. | Procedure or surgery | – |
Primary outcome
Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery
Time frame: 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
Time frame: 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.
2 secondary outcomes
Recurrence
Time frame: 1 year
Complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 41486915Kement 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naciye Cigdem Arslan, MD study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids and Quality of Life, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naciye Cigdem Arslan, MD (+905313890975, cigdemarslan@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05429060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.