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

Hemorrhoids Third Degree Clinical Trial

Official title:

Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06420986
• Other study ID #: IB4323-20PI
• Status: Completed
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: April 17, 2024

Study information

• Verified date: May 2024
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 17, 2024
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age older than 18.

• Hemorroids grade III.

• Surgical indication for hemorroid treatment.

• Signed informed consent.

Exclusion criteria:

• Acute hemorroidal disease.

• Previous hemorroidal surgery.

• Concomitant anal fissure.

• Concomitant perianal fistulae.

• Concomitant rectal prolapse.

• Inflamatory bowel disease.

• Anal or colorrectal cancer.

Related Conditions & MeSH terms

• Hemorrhoids
• Hemorrhoids Third Degree

Intervention

Procedure:
• Open Hemorrhoidectomy
Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
• Transanal Hemorrhoidal Dearterialization
Surgical treatment of Hemorrhoids. This operation involves no excision. The hemorrhoidal arteries are ligated and the hemorrhoial prolapse is treated by a suture mucopexi. Described by Rato

Locations

Country	Name	City	State
Spain	Hospital Son Llatzer	Palma De Mallorca	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Son Llatzer	Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemorrhoidal disease symptom score	A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome	one year
Primary	short health scale in hemorrhoidal disease	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	one year
Secondary	postoperative pain	pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome	1 week after surgical procedure
Secondary	fecal incontinence	measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome	baseline and 1 week, 3 months and 1 year after surgical procedure