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

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombosed External Hemorrhoid
• Intervention / Treatment: Procedure: Thrombectomy; Procedure: Hemorrhoidectomy

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Gazi University
  • Ankara, Turkey, 06560
    • Yildirim Beyazit University Yenimahalle Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Thrombectomy; Patients with thrombosed external hemorrhoids undergoing thrombectomy	Procedure: Thrombectomy; 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	Procedure: Hemorrhoidectomy; A surgery to remove the hemorrhoid, including the blood vessels and clot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Chair: Sezai Leventoglu, Professor, Gazi University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Embolism and Thrombosis; Intestinal Diseases; Rectal Diseases; Thrombosis; Hemorrhoids
• Other Study ID Numbers: GaziGenelCerrahiTEH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Derived anonymised data at the patient-level may be able to be made available for sharing
• IPD Sharing Time Frame: Following publication of the main results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No