Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms

Not Applicable

Completed

• Conditions: Hemorrhoids Third Degree
• Interventions: Procedure: Open Hemorrhoidectomy; Procedure: Transanal Hemorrhoidal Dearterialization

• Registration Number: NCT06420986
• Lead Sponsor: Hospital Son Llatzer

Brief Summary

The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is:

- Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD?

Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure.

Participants will:

* Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD.

* Fill in symptom forms before and one year after the surgical procedure.

* Attend control visits one week, one month, three months and one year after the surgical procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-12
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-17
• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-20
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemorrhoidectomy	Open Hemorrhoidectomy	-
Transanal Hemorrhoidal Dearterialization	Transanal Hemorrhoidal Dearterialization	-

Primary Outcome Measures

Name	Time	Method
hemorrhoidal disease symptom score	one year	A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome
short health scale in hemorrhoidal disease	one year	a subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
fecal incontinence	baseline and 1 week, 3 months and 1 year after surgical procedure	measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome
postoperative pain	1 week after surgical procedure	pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome

Trial Locations

Locations (1)

Hospital Son Llatzer; 🇪🇸 Palma De Mallorca, Illes Balears, Spain