An observational study in Thrombosed External Hemorrhoid, sponsored by Gazi University. Completed at 2 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Gazi University · Observational
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:
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.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 96 is below the median of 200 across 47 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who apply (or are referred) to general surgery departments and are diagnosis with thrombosed external hemorrhoids will be included in the study.
Exclusion Criteria:
Patients with thrombosed external hemorrhoids undergoing thrombectomy
Procedure: Thrombectomy
Patients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy
Procedure: Hemorrhoidectomy
A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.
A surgery to remove the hemorrhoid, including the blood vessels and clot.
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.
Time frame: 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
Time frame: 6 months from operation
Plan to share: Yes — Derived anonymised data at the patient-level may be able to be made available for sharing
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gazi University