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

NCT07333040 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-12

No results posted yet for this study

Summary

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

Conditions

  • Hemorrhoids Third Degree
  • Internal Hemorrhoids
  • Mixed Hemorrhoids

Interventions

PROCEDURE

Laser Hemorrhoidoplasty (LHP)

1470nm or 980nm diode laser ablation

PROCEDURE

Hemorrhoid Energy Therapy (HET)

Bipolar radiofrequency coagulation using HET™ system

PROCEDURE

Ferguson Hemorrhoidectomy

Standard closed excisional hemorrhoidectomy

Sponsors & Collaborators

  • Taiwan Colorectal Action Research, TCAR

    collaborator UNKNOWN

  • Chang Gung Memorial Hospital, Keelung

    collaborator UNKNOWN

  • Jen-Ai Hospital Institutional Review Board

    collaborator INDUSTRY

  • New Taipei City Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-05-01
Completion
2028-03-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07333040 on ClinicalTrials.gov