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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.