Hemorrhoids Third Degree
Conditions
Keywords
hemorrhoids third degree, botulinum Toxin, Hemorrhoidectomy, Transanal Hemorrhoidal Dearterialization, hemorrhoidal Disease Symptom Score
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.
Interventions
PROCEDUREOpen Hemorrhoidectomy
Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
PROCEDURETransanal 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
Sponsors
Hospital Son Llatzer
Fundació d'investigació Sanitària de les Illes Balears
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 1 week after surgical procedure | pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome |
| Fecal Incontinence | one year after surgical procedure | measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome |
Countries
Spain
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 7 / 25 | 11 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
None listed