Comparing Laser, Energy-Based, and Conventional Surgery for Treating Grade III Internal Hemorrhoids
A Multicenter Study to Evaluate Pain and Recovery After Different Surgical Options
Led by Chang Gung Memorial Hospital · Updated on 2026-08-07
60
Participants Needed
1
Research Sites
43 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing three surgical treatments for patients with symptomatic Goligher Grade III internal hemorrhoids Laser Hemorrhoidoplasty LHP, Hemorrhoid Energy Therapy HET, and conventional closed hemorrhoidectomy using the Ferguson technique. This prospective, multicenter study uses a preference-based design where patients choose their treatment after counseling. The goal is to see if minimally invasive energy-based therapies provide better pain relief and faster recovery than conventional surgery.
Participants select one of the three treatment options LHP using 1470nm or 980nm diode laser ablation, HET using bipolar radiofrequency coagulation with the HET system, or conventional excisional hemorrhoidectomy. The study uses statistical methods to reduce bias from patient choice. Treatments are performed once, and patients are followed up to assess outcomes.
During the study, participants will be monitored for post-operative pain from Day 1 to Day 14 and time to functional recovery up to one month. Secondary outcomes include hemorrhoid recurrence at 12 months, symptom severity, quality of life, and complications. Assessments include standardized symptom scores and photo documentation before surgery. Safety and recovery progress are tracked throughout the follow-up period, which lasts up to 12 months.
CONDITIONS
Brief Title
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Research Team
I
I-Li Lai, MD
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Diagnosed with Goligher Grade III internal hemorrhoids.
Symptomatic with HDSS score 5.
Age 18 to 75 years.
Fit for general anesthesia or sedation.
Able to provide informed consent.
Agree to pre-operative photo documentation.
You will not qualify if you...
Presence of other anorectal diseases such as fistula, abscess, inflammatory bowel disease, or malignancy.
Prior anorectal surgery within 6 months.
Pregnancy or lactation.
Contraindications to anesthesia.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single treatment event
Participants undergo their chosen surgical treatment: Laser Hemorrhoidoplasty, Hemorrhoid Energy Therapy, or Conventional Hemorrhoidectomy.
Follow-up
Duration - Up to 12 months
Participants are monitored for post-operative pain from Day 1 to Day 14 and functional recovery up to 1 month. Additional assessments include symptom severity, quality of life, and complications up to 12 months.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
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