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
Verified date | May 2024 |
Source | Hospital Son Llatzer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Son Llatzer | Palma De Mallorca | Illes Balears |
Lead Sponsor | Collaborator |
---|---|
Hospital Son Llatzer | Fundació d'investigació Sanitària de les Illes Balears |
Spain,
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 |
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