HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids

Chang Gung Medical Foundation

Status: Begins enrollment this month

Conditions: Internal Hemorrhoids; Hemorrhoids Third Degree; Mixed Hemorrhoids

Treatments: Procedure: Hemorrhoid Energy Therapy (HET); Procedure: Ferguson Hemorrhoidectomy; Procedure: Laser Hemorrhoidoplasty (LHP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07333040

202501172A3

Details and patient eligibility

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Laser Hemorrhoidoplasty (LHP)

Experimental group

Description:

1470nm or 980nm diode laser ablation

Treatment:

Procedure: Laser Hemorrhoidoplasty (LHP)

Hemorrhoid Energy Therapy (HET)

Experimental group

Description:

Bipolar radiofrequency coagulation using HET™ system

Treatment:

Procedure: Hemorrhoid Energy Therapy (HET)

Conventional Hemorrhoidectomy

Active Comparator group

Description:

Standard closed excisional hemorrhoidectomy

Treatment:

Procedure: Ferguson Hemorrhoidectomy