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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-03-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hemorrhoids Third Degree Internal Hemorrhoids Mixed Hemorrhoids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.

Study Groups

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Laser Hemorrhoidoplasty (LHP)

1470nm or 980nm diode laser ablation

Group Type EXPERIMENTAL

Laser Hemorrhoidoplasty (LHP)

Intervention Type PROCEDURE

1470nm or 980nm diode laser ablation

Hemorrhoid Energy Therapy (HET)

Bipolar radiofrequency coagulation using HET™ system

Group Type EXPERIMENTAL

Hemorrhoid Energy Therapy (HET)

Intervention Type PROCEDURE

Bipolar radiofrequency coagulation using HET™ system

Conventional Hemorrhoidectomy

Standard closed excisional hemorrhoidectomy

Group Type ACTIVE_COMPARATOR

Ferguson Hemorrhoidectomy

Intervention Type PROCEDURE

Standard closed excisional hemorrhoidectomy

Interventions

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Laser Hemorrhoidoplasty (LHP)

1470nm or 980nm diode laser ablation

Intervention Type PROCEDURE

Hemorrhoid Energy Therapy (HET)

Bipolar radiofrequency coagulation using HET™ system

Intervention Type PROCEDURE

Ferguson Hemorrhoidectomy

Standard closed excisional hemorrhoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No