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NCT07333040
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Conditions: Hemorrhoids Third Degree, Internal Hemorrhoids, Mixed Hemorrhoids
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Chang Gung Memorial Hospital
Location: Chang Gung Memorial Hospital, Linkou Branch Taoyuan
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07333040). StuddyBuddy aggregates publicly available trial information.
