Trial Outcomes & Findings for Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms (NCT NCT06420986)
NCT ID: NCT06420986
Last Updated: 2026-04-17
Results Overview
A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
one year
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
Hemorrhoidectomy
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hemorrhoidectomy
n=25 Participants
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
Transanal Hemorrhoidal Dearterialization
n=25 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 2 • n=25 Participants
|
48 years
STANDARD_DEVIATION 2 • n=25 Participants
|
48 years
STANDARD_DEVIATION 2 • n=50 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
12 Participants
n=25 Participants
|
25 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: one yearA score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome
Outcome measures
| Measure |
Hemorrhoidectomy
n=24 Participants
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
Transanal Hemorrhoidal Dearterialization
n=23 Participants
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
|
|---|---|---|
|
Hemorrhoidal Disease Symptom Score
|
1 units on a scale
Interval 0.0 to 2.0
|
7 units on a scale
Interval 2.0 to 9.0
|
PRIMARY outcome
Timeframe: one yeara 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
Outcome measures
| Measure |
Hemorrhoidectomy
n=24 Participants
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
Transanal Hemorrhoidal Dearterialization
n=23 Participants
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
|
|---|---|---|
|
Short Health Scale in Hemorrhoidal Disease
|
7 units on a scale
Interval 7.0 to 8.0
|
10 units on a scale
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: 1 week after surgical procedurepain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome
Outcome measures
| Measure |
Hemorrhoidectomy
n=25 Participants
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
Transanal Hemorrhoidal Dearterialization
n=25 Participants
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
|
|---|---|---|
|
Postoperative Pain
|
5.58 units on a scale
Standard Deviation 0.34
|
3.92 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: one year after surgical proceduremeasured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome
Outcome measures
| Measure |
Hemorrhoidectomy
n=24 Participants
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
Transanal Hemorrhoidal Dearterialization
n=23 Participants
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
|
|---|---|---|
|
Fecal Incontinence
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
Adverse Events
Hemorrhoidectomy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Transanal Hemorrhoidal Dearterialization
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hemorrhoidectomy
n=25 participants at risk
Open Hemorrhoidectomy: Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
|
Transanal Hemorrhoidal Dearterialization
n=25 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Acute Urinary retention
|
0.00%
0/25 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
8.0%
2/25 • Number of events 2 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
|
Nervous system disorders
Prolonged pain
|
20.0%
5/25 • Number of events 5 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
20.0%
5/25 • Number of events 5 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
4.0%
1/25 • Number of events 1 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
|
Surgical and medical procedures
Bleeding
|
8.0%
2/25 • Number of events 2 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
16.0%
4/25 • Number of events 4 • 30 days
We used Claven-Dindo classification a Comprehensive Complication Index
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place