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

NCT ID: NCT03903536

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-06-01

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.

Conditions

Thrombosed External Hemorrhoid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Thrombectomy

Patients with thrombosed external hemorrhoids undergoing thrombectomy

Thrombectomy

Intervention Type: PROCEDURE

A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.

Local excision/ Hemorrhoidectomy

Patients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy

Hemorrhoidectomy

Intervention Type: PROCEDURE

A surgery to remove the hemorrhoid, including the blood vessels and clot.

Interventions

Thrombectomy

A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.

Intervention Type: PROCEDURE

Hemorrhoidectomy

A surgery to remove the hemorrhoid, including the blood vessels and clot.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ali Yalcinkaya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sezai Leventoglu, Professor

Role: STUDY_CHAIR

Gazi University Hospital

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Yildirim Beyazit University Yenimahalle Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziGenelCerrahiTEH

Identifier Type: -

Identifier Source: org_study_id