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

G

Gazi University

Status

Completed

Conditions

Thrombosed External Hemorrhoid

Treatments

Procedure: Thrombectomy
Procedure: Hemorrhoidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT03903536
GaziGenelCerrahiTEH

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

96 participants in 2 patient groups

Thrombectomy
Description:
Patients with thrombosed external hemorrhoids undergoing thrombectomy
Treatment:
Procedure: Thrombectomy
Local excision/ Hemorrhoidectomy
Description:
Patients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy
Treatment:
Procedure: Hemorrhoidectomy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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