Hemorrhoids Third DegreeNCT06420986
Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms
A study testing Open Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization in people with Hemorrhoids Third Degree, run by Hospital Son Llatzer at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids Third Degree
- What is being tested?
- Open Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 12 Aug 2021to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18.
- Hemorroids grade III.
- Surgical indication for hemorroid treatment.
- Signed informed consent.
Who cannot join
- Acute hemorroidal disease.
- Previous hemorroidal surgery.
- Concomitant anal fissure.
- Concomitant perianal fistulae.
- Concomitant rectal prolapse.
- Inflamatory bowel disease.
- Anal or colorrectal cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial
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?
Read more
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.
- Conditions
- Hemorrhoids Third Degree
- Being tested
- Open Hemorrhoidectomy, Transanal Hemorrhoidal Dearterialization
- Keywords
- hemorrhoids third degree, botulinum Toxin, Hemorrhoidectomy, Transanal Hemorrhoidal Dearterialization, hemorrhoidal Disease Symptom Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open HemorrhoidectomyProcedure or surgery
Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan
Transanal Hemorrhoidal DearterializationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhoidectomy | Experimental | Not described Receives: Procedure: Open Hemorrhoidectomy |
| Transanal Hemorrhoidal Dearterialization | Experimental | Not described Receives: Procedure: Transanal Hemorrhoidal Dearterialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Secondary outcomes (2)
Postoperative Pain
pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome
Measured: 1 week after surgical procedure
Fecal Incontinence
measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome
Measured: one year after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start12 Aug 2021
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoids Third DegreeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
- Responsible party
- Principal investigator, Ignacio Fernandez Hurtado, Hospital Son Llatzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420986
- Sponsor's protocol ID
- IB4323-20PI
- Status last verified
- Apr 2026
- First submitted
- 15 May 2024
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41553737
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06420986
- Acronym / sponsor ID
- IB4323-20PI
- Conditions
- Hemorrhoids Third Degree
- Keywords
- hemorrhoids third degree, botulinum Toxin, Hemorrhoidectomy, Transanal Hemorrhoidal Dearterialization, hemorrhoidal Disease Symptom Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Collaborators
- Fundació d'investigació Sanitària de les Illes Balears
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemorrhoidectomy | Experimental | Procedure: Open Hemorrhoidectomy |
| Transanal Hemorrhoidal Dearterialization | Experimental | Procedure: Transanal Hemorrhoidal Dearterialization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 18.
- Hemorroids grade III.
- Surgical indication for hemorroid treatment.
- Signed informed consent.
Key exclusion criteria (7 listed)
- Acute hemorroidal disease.
- Previous hemorroidal surgery.
- Concomitant anal fissure.
- Concomitant perianal fistulae.
- Concomitant rectal prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open HemorrhoidectomySurgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan | Procedure or surgery | Hemorrhoidectomy |
| Transanal Hemorrhoidal DearterializationSurgical 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 | Procedure or surgery | Transanal Hemorrhoidal Dearterialization |
Primary outcome
Hemorrhoidal Disease Symptom Score
Time frame: 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
Time frame: 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
2 secondary outcomes
Postoperative Pain
Time frame: 1 week after surgical procedure
Fecal Incontinence
Time frame: one year after surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41553737Fernandez-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.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids Third Degree
Not yet recruitingPhase 2
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
Recruiting
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Hemorrhoids Third Degree, Internal Hemorrhoids
Recruiting
PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)
Hemorrhoids, Hemorrhoids Third Degree
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization in people with Hemorrhoids Third Degree, run by Hospital Son Llatzer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhoidal Disease Symptom Score (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.