Hemorrhoids Third DegreeHELONCT07333040
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
A study testing Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET) and Ferguson Hemorrhoidectomy in people with Hemorrhoids Third Degree and Internal Hemorrhoids, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This prospective, multicenter study compares the efficacy and functional outcomes of three surgical treatments for symptomatic Goligher Grade III internal hemorrhoids: Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), and conventional closed hemorrhoidectomy (Ferguson technique). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids Third Degree, Internal Hemorrhoids, Mixed Hemorrhoids
- What is being tested?
- Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET) and Ferguson Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Goligher Grade III internal hemorrhoids.
- Symptomatic with HDSS score >= 5.
- Age 18-75 years.
- Fit for general anesthesia or sedation.
- Able to provide informed consent.
- Agree to pre-operative photo documentation.
Who cannot join
- Other anorectal diseases (fistula, abscess, IBD, malignancy).
- Prior anorectal surgery within 6 months.
- Pregnancy or lactation.
- Contraindications to anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, 333
I-Li Lai, MD, +886-3-3281200 ext. 2101, ryane92a5@cgmh.org.tw
About this study
Official title: Hemorrhoidectomy, Energy-Based, and Laser Outcomes in Grade III Hemorrhoids: A Prospective, Multicenter, Preference-Based Comparative Study
This prospective, multicenter study compares the efficacy and functional outcomes of three surgical treatments for symptomatic Goligher Grade III internal hemorrhoids: Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), and conventional closed hemorrhoidectomy (Ferguson technique). Due to strong patient preferences in hemorrhoidal surgery, this study utilizes a pragmatic, preference-tolerant design. Eligible patients will undergo standardized counseling and select their preferred treatment arm. The study aims to evaluate whether minimally invasive energy-based therapies offer superior postoperative pain relief and faster functional recovery compared to conventional hemorrhoidectomy
Read the detailed description
This prospective, multicenter trial aims to evaluate and optimize the surgical management of Goligher Grade III internal hemorrhoids. While conventional excisional hemorrhoidectomy (Ferguson technique) remains the gold standard, it is associated with significant postoperative pain and prolonged recovery. Emerging energy-based therapies, specifically Laser Hemorrhoidoplasty (LHP) and Hemorrhoid Energy Therapy (HET), offer potential advantages but their comparative efficacy remains understudied.
The study employs a pragmatic, preference-based design to reflect real-world clinical decision-making. Eligible participants will receive standardized counseling regarding three treatment options: (1) LHP, (2) HET, and (3) Conventional Hemorrhoidectomy, and will be assigned to their preferred treatment arm. To mitigate selection bias, propensity score overlap weighting (PSOW) will be utilized in the statistical analysis.
The primary objective is to compare the postoperative pain trajectory (assessed by the Area Under the Curve of NRS pain scores from Day 1 to Day 14) and the time to functional recovery among the three groups. Secondary objectives include the assessment of 12-month recurrence rates, symptom severity (HDSS), quality of life (Short Health Scale), and postoperative complications. Recurrence outcomes will be adjudicated by an independent blinded committee to minimize detection bias.
- Being tested
- Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), Ferguson Hemorrhoidectomy
- Keywords
- Laser Hemorrhoidoplasty, Hemorrhoid Energy Therapy, Postoperative Pain, Minimally Invasive Surgery, Hemorrhoidectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Hemorrhoidoplasty (LHP)Procedure or surgery
1470nm or 980nm diode laser ablation
Hemorrhoid Energy Therapy (HET)Procedure or surgery
Bipolar radiofrequency coagulation using HET™ system
Ferguson HemorrhoidectomyProcedure or surgery
Standard closed excisional hemorrhoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Laser Hemorrhoidoplasty (LHP) | Experimental | 1470nm or 980nm diode laser ablation Receives: Procedure: Laser Hemorrhoidoplasty (LHP) |
| Hemorrhoid Energy Therapy (HET) | Experimental | Bipolar radiofrequency coagulation using HET™ system Receives: Procedure: Hemorrhoid Energy Therapy (HET) |
| Conventional Hemorrhoidectomy | Active comparator | Standard closed excisional hemorrhoidectomy Receives: Procedure: Ferguson Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Functional Recovery
Days to return to work or normal daily activities.
Measured: Up to 1 month post-operation
Post-operative Pain Trajectory (Area Under the Curve)
Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).
Measured: Post-operative Day 1 to Day 14
Secondary outcomes (1)
Recurrence Rate
Defined as the recurrence of prolapse or bleeding requiring medical or surgical re-intervention, or deterioration in HDSS score beyond a prespecified threshold. To ensure objectivity, these events will be adjudicated by an independent committee blinded to the treatment allocation.
Measured: 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jul 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Colorectal Action Research Society, New Taipei Municipal TuCheng Hospital, Jen Ai Hospital
- Responsible party
- Principal investigator, I-Li Lai, MD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333040
- Sponsor's protocol ID
- 202501172A3
- Acronym
- HELO
- Status last verified
- Aug 2026
- First submitted
- 1 Jan 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HollAND Study Group. Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial. Dis Colon Rectum. 2025 May 1;68(5):572-583. doi: 10.1097/DCR.0000000000003679. Epub 2025 Feb 14.
PubMed 39952268Gambardella C, Brusciano L, Brillantino A, Parisi S, Lucido FS, Del Genio G, Tolone S, Allaria A, Di Saverio S, Pizza F, Sturiale A, Docimo L. Mid-term efficacy and postoperative wound management of laser hemorrhoidoplasty (LHP) vs conventional excisional hemorrhoidectomy in grade III hemorrhoidal disease: the twisting trend. Langenbecks Arch Surg. 2023 Apr 5;408(1):140. doi: 10.1007/s00423-023-02879-4.
PubMed 37020091Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
PubMed 38294832Giuliani A, Romano L, Necozione S, Cofini V, Di Donato G, Schietroma M, Carlei F; EMODART3 Study Group. Excisional Hemorrhoidectomy Versus Dearterialization With Mucopexy for the Treatment of Grade III Hemorrhoidal Disease: The EMODART3 Multicenter Study. Dis Colon Rectum. 2023 Dec 1;66(12):e1254-e1263. doi: 10.1097/DCR.0000000000002885. Epub 2023 Aug 24.
PubMed 37616177
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidectomy, Energy-Based, and Laser Outcomes in Grade III Hemorrhoids: A Prospective, Multicenter, Preference-Based Comparative Study
- ClinicalTrials.gov ID
- NCT07333040
- Acronym / sponsor ID
- HELO / 202501172A3
- Keywords
- Laser Hemorrhoidoplasty, Hemorrhoid Energy Therapy, Postoperative Pain, Minimally Invasive Surgery, Hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Taiwan Colorectal Action Research Society, New Taipei Municipal TuCheng Hospital, Jen Ai Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicenter study compares the efficacy and functional outcomes of three surgical treatments for symptomatic Goligher Grade III internal hemorrhoids: Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), and conventional closed hemorrhoidectomy (Ferguson technique). Due to strong patient preferences in hemorrhoidal surgery, this study utilizes a pragmatic, preference-tolerant design. Eligible patients will undergo standardized counseling and select their preferred treatment arm. The study aims to evaluate whether minimally invasive energy-based therapies offer superior postoperative pain relief and faster functional recovery compared to conventional hemorrhoidectomy
Detailed description
This prospective, multicenter trial aims to evaluate and optimize the surgical management of Goligher Grade III internal hemorrhoids. While conventional excisional hemorrhoidectomy (Ferguson technique) remains the gold standard, it is associated with significant postoperative pain and prolonged recovery. Emerging energy-based therapies, specifically Laser Hemorrhoidoplasty (LHP) and Hemorrhoid Energy Therapy (HET), offer potential advantages but their comparative efficacy remains understudied.
The study employs a pragmatic, preference-based design to reflect real-world clinical decision-making. Eligible participants will receive standardized counseling regarding three treatment options: (1) LHP, (2) HET, and (3) Conventional Hemorrhoidectomy, and will be assigned to their preferred treatment arm. To mitigate selection bias, propensity score overlap weighting (PSOW) will be utilized in the statistical analysis.
The primary objective is to compare the postoperative pain trajectory (assessed by the Area Under the Curve of NRS pain scores from Day 1 to Day 14) and the time to functional recovery among the three groups. Secondary objectives include the assessment of 12-month recurrence rates, symptom severity (HDSS), quality of life (Short Health Scale), and postoperative complications. Recurrence outcomes will be adjudicated by an independent blinded committee to minimize detection bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.
| Arm | Type | Receives |
|---|---|---|
| Laser Hemorrhoidoplasty (LHP) | Experimental | Procedure: Laser Hemorrhoidoplasty (LHP)1470nm or 980nm diode laser ablation |
| Hemorrhoid Energy Therapy (HET) | Experimental | Procedure: Hemorrhoid Energy Therapy (HET)Bipolar radiofrequency coagulation using HET™ system |
| Conventional Hemorrhoidectomy | Active comparator | Procedure: Ferguson HemorrhoidectomyStandard closed excisional hemorrhoidectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Goligher Grade III internal hemorrhoids.
- Symptomatic with HDSS score >= 5.
- Age 18-75 years.
- Fit for general anesthesia or sedation.
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- Other anorectal diseases (fistula, abscess, IBD, malignancy).
- Prior anorectal surgery within 6 months.
- Pregnancy or lactation.
- Contraindications to anesthesia.
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 |
|---|---|---|
| Laser Hemorrhoidoplasty (LHP)1470nm or 980nm diode laser ablation | Procedure or surgery | Laser Hemorrhoidoplasty (LHP) |
| Hemorrhoid Energy Therapy (HET)Bipolar radiofrequency coagulation using HET™ system | Procedure or surgery | Hemorrhoid Energy Therapy (HET) |
| Ferguson HemorrhoidectomyStandard closed excisional hemorrhoidectomy | Procedure or surgery | Conventional Hemorrhoidectomy |
Primary outcome
Time to Functional Recovery
Time frame: Up to 1 month post-operation
Days to return to work or normal daily activities.
Post-operative Pain Trajectory (Area Under the Curve)
Time frame: Post-operative Day 1 to Day 14
Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).
1 secondary outcome
Recurrence Rate
Time frame: 12 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 39952268van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HollAND Study Group. Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial. Dis Colon Rectum. 2025 May 1;68(5):572-583. doi: 10.1097/DCR.0000000000003679. Epub 2025 Feb 14.
- Background: PubMed 37020091Gambardella C, Brusciano L, Brillantino A, Parisi S, Lucido FS, Del Genio G, Tolone S, Allaria A, Di Saverio S, Pizza F, Sturiale A, Docimo L. Mid-term efficacy and postoperative wound management of laser hemorrhoidoplasty (LHP) vs conventional excisional hemorrhoidectomy in grade III hemorrhoidal disease: the twisting trend. Langenbecks Arch Surg. 2023 Apr 5;408(1):140. doi: 10.1007/s00423-023-02879-4.
- Background: PubMed 38294832Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
- Background: PubMed 37616177Giuliani A, Romano L, Necozione S, Cofini V, Di Donato G, Schietroma M, Carlei F; EMODART3 Study Group. Excisional Hemorrhoidectomy Versus Dearterialization With Mucopexy for the Treatment of Grade III Hemorrhoidal Disease: The EMODART3 Multicenter Study. Dis Colon Rectum. 2023 Dec 1;66(12):e1254-e1263. doi: 10.1097/DCR.0000000000002885. Epub 2023 Aug 24.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET) and Ferguson Hemorrhoidectomy in people with Hemorrhoids Third Degree and Internal Hemorrhoids, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Aug 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact I-Li Lai, MD (+886911978067, ryane92a5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Functional Recovery (time frame: Up to 1 month post-operation). 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 NCT07333040, which also lists 4 linked publications.
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 7 Aug 2026.