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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChang Gung Memorial Hospital

About this trial

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

Eligibility criteria

Qualifiers

Diagnosed with Goligher Grade III internal hemorrhoids.

Symptomatic with HDSS score >= 5.

Age 18-75 years.

Fit for general anesthesia or sedation.

Disqualifiers

Other anorectal diseases (fistula, abscess, IBD, malignancy).

Prior anorectal surgery within 6 months.

Pregnancy or lactation.

Contraindications to anesthesia.

Trial design

Treatments tested in this trial

  • Laser Hemorrhoidoplasty (LHP)
  • Hemorrhoid Energy Therapy (HET)
  • Ferguson Hemorrhoidectomy

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Chang Gung Memorial Hospital

Lead sponsor

Taiwan Colorectal Action Research, TCAR

Collaborator

Chang Gung Memorial Hospital, Keelung

Collaborator

Jen-Ai Hospital Institutional Review Board

Collaborator

New Taipei City Hospital

Collaborator