Hemorrhoidectomy, Energy-Based, and Laser Outcomes in Grade III Hemorrhoids: A Prospective, Multicenter, Preference-Based Comparative Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time to Functional Recovery
Overview
Brief 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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with Goligher Grade III internal hemorrhoids.
- •Symptomatic with HDSS score \>=
- •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.
Outcomes
Primary Outcomes
Time to Functional Recovery
Time Frame: Up to 1 month post-operation
Days to return to work or normal daily activities.
Post-operative Pain Trajectory (Area Under the Curve)
Time Frame: Post-operative Day 1 to Day 14
Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).
Secondary Outcomes
- Recurrence Rate(12 months post-operation)
Investigators
I-Li Lai, MD
Assistant Professor
Chang Gung Memorial Hospital