Hemorrhoidectomy, Energy-Based, and Laser Outcomes in Grade III Hemorrhoids: A Prospective, Multicenter, Preference-Based Comparative Study
| Registry | NCT07333040, acronym HELO |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: single, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Chang Gung Memorial Hospital (Other); collaborators: Taiwan Colorectal Action Research Society, New Taipei Municipal TuCheng Hospital, Jen Ai Hospital |
| Conditions | Hemorrhoids Third Degree, Internal Hemorrhoids, Mixed Hemorrhoids |
| Interventions | Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), Ferguson Hemorrhoidectomy (Procedure) |
| Dates | start 2026-07-01, primary completion 2027-05-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-01-12, last updated 2026-08-07 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Hemorrhoids Third Degree All trials for Internal Hemorrhoids All trials of Laser Hemorrhoidoplasty (LHP) All trials of Hemorrhoid Energy Therapy (HET)
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Laser Hemorrhoidoplasty (LHP) | Experimental | Procedure: Laser Hemorrhoidoplasty (LHP) | 1470nm or 980nm diode laser ablation |
| Hemorrhoid Energy Therapy (HET) | Experimental | Procedure: Hemorrhoid Energy Therapy (HET) | Bipolar radiofrequency coagulation using HET™ system |
| Conventional Hemorrhoidectomy | Active comparator | Procedure: Ferguson Hemorrhoidectomy | Standard closed excisional hemorrhoidectomy |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou Branch | Taoyuan | Taiwan | Recruiting |