Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome (TEH)

Thrombosed External Hemorrhoid Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903536
• Other study ID #: GaziGenelCerrahiTEH
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhoids
• Thrombosed External Hemorrhoid
• Thrombosis

Intervention

Procedure:
• Thrombectomy
A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.
• Hemorrhoidectomy
A surgery to remove the hemorrhoid, including the blood vessels and clot.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara
Turkey	Yildirim Beyazit University Yenimahalle Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months from operation
Primary	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	6 months from operation