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

NCT03903536 | Completed

• 1 other identifier: GaziGenelCerrahiTEH
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Thrombectomy

Patients with thrombosed external hemorrhoids undergoing thrombectomy

Procedure: Thrombectomy

Local excision/ Hemorrhoidectomy

Patients with thrombosed external hemorrhoids undergoing local excision/ hemorrhoidectomy

Procedure: Hemorrhoidectomy

Interventions

Thrombectomy PROCEDURE

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

Thrombectomy

Hemorrhoidectomy PROCEDURE

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

Local excision/ Hemorrhoidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

Yildirim Beyazit University Yenimahalle Training and Research Hospital

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Thrombectomy; Hemorrhoidectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Sezai Leventoglu, Professor

  Gazi University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication of the main results

Locations

TU (2)