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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06420986
Other study ID # IB4323-20PI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03757728 - Randomized Trial :Hemorrhoidal Pedicle Ligation vs Laser vs Open Hemorrhoidectomy N/A
Completed NCT03848468 - Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids. N/A