An interventional study of Laser Hemorrhoidoplasty (LHP) and Hemorrhoid Energy Therapy (HET) in Hemorrhoids Third Degree, Internal Hemorrhoids and Mixed Hemorrhoids, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
1470nm or 980nm diode laser ablation
Procedure: Laser Hemorrhoidoplasty (LHP)
Bipolar radiofrequency coagulation using HET™ system
Procedure: Hemorrhoid Energy Therapy (HET)
Standard closed excisional hemorrhoidectomy
Procedure: Ferguson Hemorrhoidectomy
1470nm or 980nm diode laser ablation
Bipolar radiofrequency coagulation using HET™ system
Standard closed excisional hemorrhoidectomy
Time to Functional Recovery
Days to return to work or normal daily activities.
Time frame: Up to 1 month post-operation
Post-operative Pain Trajectory (Area Under the Curve)
Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).
Time frame: Post-operative Day 1 to Day 14
Recurrence Rate
Defined as the recurrence of prolapse or bleeding requiring medical or surgical re-intervention, or deterioration in HDSS score beyond a prespecified threshold. To ensure objectivity, these events will be adjudicated by an independent committee blinded to the treatment allocation.
Time frame: 12 months post-operation
Plan to share: Undecided
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Chang Gung Memorial Hospital