HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChang Gung Memorial Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Goligher Grade III internal hemorrhoids.
Symptomatic with HDSS score >= 5.
Age 18-75 years.
Fit for general anesthesia or sedation.
Disqualifiers
Other anorectal diseases (fistula, abscess, IBD, malignancy).
Prior anorectal surgery within 6 months.
Pregnancy or lactation.
Contraindications to anesthesia.
Trial design
Design model
Parallel
Treatments tested in this trial
Laser Hemorrhoidoplasty (LHP)
Procedure/Surgery1470nm or 980nm diode laser ablation
Hemorrhoid Energy Therapy (HET)
Procedure/SurgeryBipolar radiofrequency coagulation using HET™ system
Ferguson Hemorrhoidectomy
Procedure/SurgeryStandard closed excisional hemorrhoidectomy
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Laser Hemorrhoidoplasty (LHP)Experimental treatment 1 intervention
Group B: Hemorrhoid Energy Therapy (HET)Experimental treatment 1 intervention
Group C: Conventional HemorrhoidectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Functional Recovery
Days to return to work or normal daily activities.
Time frame
Up to 1 month post-operation2
Post-operative Pain Trajectory (Area Under the Curve)
Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).
Time frame
Post-operative Day 1 to Day 14Secondary 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.
Time frame
12 months post-operationSponsors and contacts
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Chang Gung Memorial Hospital
Lead sponsor
Taiwan Colorectal Action Research Society
Collaborator
New Taipei Municipal TuCheng Hospital
Collaborator
Jen Ai Hospital
Collaborator
Source ClinicalTrials.gov