Thrombosed External HemorrhoidTEHNCT03903536
Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome (TEH)
An observational study of Thrombosed External Hemorrhoid, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
The primary aim of the current study is to evaluate and compare 6-month complication rates after thrombectomy and local excision treatments. The investigators aim to compare thrombectomy and local excision treatments in many different aspects: The investigators will follow these patients for 6 months by scheduling… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosed External Hemorrhoid
- What is being tested?
- Thrombectomy and Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Jun 2022
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who apply (or are referred) to general surgery departments and are diagnosis with thrombosed external hemorrhoids will be included in the study.
Who may be able to join
- Patients who are diagnosis with thrombosed external hemorrhoids.
- Providing a written informed consent form for the surgeries and for participation in the study
- Patients aged 18 years and over should be included
Who cannot join
- Patients younger than 18 years of age,
- Pregnancy
- Patients who have a history of cancer or inflammatory bowel disease(IBD)
- Patients who have a history of anorectal fistula
- Patients with metabolic disorders
- Patients with alcohol or substance addiction
- Patients who refuse to participate in the study and do not provide informed consent
- Patients who, at any stage of the study, indicate that they want to leave the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University
Ankara, 06560
Yildirim Beyazit University Yenimahalle Training and Research Hospital
Ankara, 06560
About this study
Official title: Treatment of Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome: A Multi-Centre, International, Prospective Cohort Study
The primary aim of the current study is to evaluate and compare 6-month complication rates after thrombectomy and local excision treatments.
The investigators aim to compare thrombectomy and local excision treatments in many different aspects:
Read more
- The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month).
- The investigators will examine bleeding, pain, anal stricture/stenosis, infection, time until return to normal daily activity, relapse and incontinence after treatment
- To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in patients.
- The investigators will use the Wexner incontinence score for assessment of incontinence.
In each hospital, medical students, residents and surgeons can be involved in the study. In the following 6-month period, all collaborators will be collecting the data of the patients who have been operated for external hemorrhoids via the thrombectomy or local excision procedures.
- Conditions
- Thrombosed External Hemorrhoid
- Being tested
- Thrombectomy, Hemorrhoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyProcedure or surgery
A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.
HemorrhoidectomyProcedure or surgery
A surgery to remove the hemorrhoid, including the blood vessels and clot.
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy | Patients with thrombosed external hemorrhoids undergoing thrombectomy Receives: Procedure: Thrombectomy | |
| Local excision/ Hemorrhoidectomy | Patients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy Receives: Procedure: Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month complication rate
- The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month).
- The investigators will examine anal bleeding(exist or not), pain(exist or not), anal stricture/stenosis(exist or not, its severity), infection(exist or not), time until return to normal daily activity, relapse and incontinence after treatment.
- The investigators will use the Wexner incontinence score for assessment of incontinence.
- The investigators will measure the internal diameter of anal canal for the assessment of anal stenosis and its severity. When the internal diameter of anal canal is less than 0.5 cm, it is severe stenosis and when the diameter is 0.5-1 cm stenosis is moderate and 1-1.5 cm diameter is known as mild stenosis.
Measured: 6 months from operation
6-month quality of life outcomes
Quality of life outcomes within 6 months of surgical procedure. To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Sections:
- Vitality
- Physical functioning
- Bodily pain
- General health perceptions
- Physical role functioning
- Emotional role functioning
- Social role functioning
- Mental health
Measured: 6 months from operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosed External HemorrhoidStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 96 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yalcinkaya, Gazi University
- Investigators
- Sezai Leventoglu, Professor, Study chair, Gazi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903536
- Sponsor's protocol ID
- GaziGenelCerrahiTEH
- Acronym
- TEH
- Status last verified
- Jul 2023
- First submitted
- 1 Apr 2019
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Derived anonymised data at the patient-level may be able to be made available for sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome: A Multi-Centre, International, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03903536
- Acronym / sponsor ID
- TEH / GaziGenelCerrahiTEH
- Conditions
- Thrombosed External Hemorrhoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 4 Apr 2019 (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.
The primary aim of the current study is to evaluate and compare 6-month complication rates after thrombectomy and local excision treatments.
The investigators aim to compare thrombectomy and local excision treatments in many different aspects:
- The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month).
- The investigators will examine bleeding, pain, anal stricture/stenosis, infection, time until return to normal daily activity, relapse and incontinence after treatment
- To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in patients.
- The investigators will use the Wexner incontinence score for assessment of incontinence.
In each hospital, medical students, residents and surgeons can be involved in the study. In the following 6-month period, all collaborators will be collecting the data of the patients who have been operated for external hemorrhoids via the thrombectomy or local excision procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy | – | Procedure: ThrombectomyPatients with thrombosed external hemorrhoids undergoing thrombectomy |
| Local excision/ Hemorrhoidectomy | – | Procedure: HemorrhoidectomyPatients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply (or are referred) to general surgery departments and are diagnosis with thrombosed external hemorrhoids will be included in the study.
Key inclusion criteria (3 listed)
- Patients who are diagnosis with thrombosed external hemorrhoids.
- Providing a written informed consent form for the surgeries and for participation in the study
- Patients aged 18 years and over should be included
Key exclusion criteria (8 listed)
- Patients younger than 18 years of age,
- Pregnancy
- Patients who have a history of cancer or inflammatory bowel disease(IBD)
- Patients who have a history of anorectal fistula
- Patients with metabolic disorders
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 |
|---|---|---|
| ThrombectomyA small procedure where surgeons make a cut in the hemorrhoid and drain the blood. | Procedure or surgery | Thrombectomy |
| HemorrhoidectomyA surgery to remove the hemorrhoid, including the blood vessels and clot. | Procedure or surgery | Local excision/ Hemorrhoidectomy |
Primary outcome
6-month complication rate
Time frame: 6 months from operation
* The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month). * The investigators will examine anal bleeding(exist or not), pain(exist or not), anal stricture/stenosis(exist or not, its severity), infection(exist or not), time until return to normal daily activity, relapse and incontinence after treatment. * The investigators will use the Wexner incontinence score for assessment of incontinence. * The investigators will measure the internal diameter of anal canal for the assessment of anal stenosis and its severity. When the internal diameter of anal canal is less than 0.5 cm, it is severe stenosis and when the diameter is 0.5-1 cm stenosis is moderate and 1-1.5 cm diameter is known as mild stenosis.
6-month quality of life outcomes
Time frame: 6 months from operation
Quality of life outcomes within 6 months of surgical procedure. To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability. Sections: * Vitality * Physical functioning * Bodily pain * General health perceptions * Physical role functioning * Emotional role functioning * Social role functioning * Mental health
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Yes. Derived anonymised data at the patient-level may be able to be made available for sharing
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.
Sezai Leventoglu, Professor study chair
Gazi University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosed External Hemorrhoid, run by Gazi University at 2 sites 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month complication rate (time frame: 6 months from operation). 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?
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 18 Jul 2023.