Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundació d'investigació Sanitària de les Illes Balears | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorrhoidectomy | Experimental |
| |
| Transanal Hemorrhoidal Dearterialization | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Hemorrhoidectomy | Procedure | Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome | 1 week after surgical procedure |
| Fecal Incontinence | measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41553737 | Result | Fernandez-Hurtado I, Pages-Valle N, Sarubbo MF, Claramonte-Bellmunt O, Baena-Bradaschia S, Cifuentes-Rodenas JA, Serra-Aracil X. Open excisional haemorrhoidectomy versus transanal haemorrhoidal dearterialization for grade III haemorrhoids: open-label randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf282. doi: 10.1093/bjs/znaf282. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hemorrhoidectomy | Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan |
| FG001 | Transanal Hemorrhoidal Dearterialization | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hemorrhoidectomy | Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan |
| BG001 | Transanal Hemorrhoidal Dearterialization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | one year |
|
30 days
We used Claven-Dindo classification a Comprehensive Complication Index
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemorrhoidectomy | Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Urinary retention | Renal and urinary disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Fernandez | Hospital Son Llatzer | +3487120000 | 2134 | ifernandez@hsll.es |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2020 | Mar 11, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Transanal Hemorrhoidal Dearterialization | Procedure | 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 |
|
| one year after surgical procedure |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | one year |
|
|
|
| Secondary | Postoperative Pain | pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome | Posted | Mean | Standard Deviation | units on a scale | 1 week after surgical procedure |
|
|
|
| Secondary | Fecal Incontinence | measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome | Posted | Median | Inter-Quartile Range | units on a scale | one year after surgical procedure |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | Transanal Hemorrhoidal Dearterialization | 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 | 0 | 25 | 0 | 25 | 11 | 25 |
| Prolonged pain | Nervous system disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
Not provided