HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Sponsored by Chang Gung Memorial Hospital
About this trial
Last updated 3 months ago
Study ID
202501172A3
Status
Not yet recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 75 Years
All Sexes
Trial Timing
Started 2 months ago
What is this trial about?
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
What are the participation requirements?
Inclusion Criteria
* 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.
Exclusion Criteria
* Other anorectal diseases (fistula, abscess, IBD, malignancy).
* Prior anorectal surgery within 6 months.
* Pregnancy or lactation.
* Contraindications to anesthesia.
