Hemorrhoids Third Degree, Internal Hemorrhoids, Mixed Hemorrhoids
Conditions
Keywords
Laser Hemorrhoidoplasty, Hemorrhoid Energy Therapy, Postoperative Pain, Minimally Invasive Surgery, Hemorrhoidectomy
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.
Interventions
PROCEDURELaser Hemorrhoidoplasty (LHP)
1470nm or 980nm diode laser ablation
PROCEDUREHemorrhoid Energy Therapy (HET)
Bipolar radiofrequency coagulation using HET™ system
PROCEDUREFerguson Hemorrhoidectomy
Standard closed excisional hemorrhoidectomy
Sponsors
Chang Gung Memorial Hospital
Taiwan Colorectal Action Research Society
New Taipei Municipal TuCheng Hospital
Jen Ai Hospital
Study design
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.
Intervention model 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
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Functional Recovery | Up to 1 month post-operation | Days to return to work or normal daily activities. |
| Post-operative Pain Trajectory (Area Under the Curve) | Post-operative Day 1 to Day 14 | Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 12 months post-operation | 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. |
Countries
Taiwan
Contacts
CONTACTI-Li Lai, MD
Outcome results
None listed