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

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ClinicalTrials.gov Identifier: NCT03903536
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Yalcinkaya, Gazi University

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.


Condition or disease Intervention/treatment
Thrombosed External Hemorrhoid Procedure: Thrombectomy Procedure: Hemorrhoidectomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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.




Primary Outcome Measures :
  1. 6-month complication rate [ Time Frame: 6 months from operation ]
    • 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.

  2. 6-month quality of life outcomes [ Time Frame: 6 months from operation ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903536


Contacts
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Contact: Ali Yalcinkaya (+90)5334254560 ali.yalcinkaya@gazi.edu.tr
Contact: Can Sahin (+90)5389531468 cansahin@gazi.edu.tr

Locations
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Turkey
Gazi University Recruiting
Ankara, Turkey, 06560
Contact: Ali Yalcinkaya, Dr    +905334254560    aliyalcink@gmail.com   
Sub-Investigator: Can Sahin, Dr         
Yildirim Beyazit University Yenimahalle Training and Research Hospital Recruiting
Ankara, Turkey, 06560
Contact: Alp Yildiz, Dr       alpyildiz.dr@gmail.com   
Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Sezai Leventoglu, Professor Gazi University Hospital
Additional Information:

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Responsible Party: Ali Yalcinkaya, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier: NCT03903536    
Other Study ID Numbers: GaziGenelCerrahiTEH
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Derived anonymised data at the patient-level may be able to be made available for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Following publication of the main results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Thrombosis
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis