Clinical trial NCT03903536: Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome (TEH)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosed External Hemorrhoid
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 6-month complication rate
timeFrame: 6 months from operation
measure: 6-month quality of life outcomes
timeFrame: 6 months from operation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Ankara
country: Turkey
facility: Yildirim Beyazit University Yenimahalle Training and Research Hospital
Study officials:
affiliation: Gazi University Hospital
name: Sezai Leventoglu, Professor
role: STUDY_CHAIR
References: