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| Name | Class |
|---|---|
| Taiwan Colorectal Action Research, TCAR | UNKNOWN |
| Chang Gung Memorial Hospital, Keelung | UNKNOWN |
| Jen-Ai Hospital Institutional Review Board | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Hemorrhoidoplasty (LHP) | Experimental | 1470nm or 980nm diode laser ablation |
|
| Hemorrhoid Energy Therapy (HET) | Experimental | Bipolar radiofrequency coagulation using HETâ„¢ system |
|
| Conventional Hemorrhoidectomy | Active Comparator | Standard closed excisional hemorrhoidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Hemorrhoidoplasty (LHP) | Procedure | 1470nm or 980nm diode laser ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Functional Recovery | Days to return to work or normal daily activities. | 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). | Post-operative Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| I-Li Lai, MD | Contact | +886911978067 | ryane92a5@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou Branch | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39952268 | Background | van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HollAND Study Group. Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial. Dis Colon Rectum. 2025 May 1;68(5):572-583. doi: 10.1097/DCR.0000000000003679. Epub 2025 Feb 14. | |
| 37020091 |
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| New Taipei City Hospital |
| OTHER |
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.
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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.
| Hemorrhoid Energy Therapy (HET) | Procedure | Bipolar radiofrequency coagulation using HETâ„¢ system |
|
| Ferguson Hemorrhoidectomy | Procedure | Standard closed excisional hemorrhoidectomy |
|
| Background |
| Gambardella C, Brusciano L, Brillantino A, Parisi S, Lucido FS, Del Genio G, Tolone S, Allaria A, Di Saverio S, Pizza F, Sturiale A, Docimo L. Mid-term efficacy and postoperative wound management of laser hemorrhoidoplasty (LHP) vs conventional excisional hemorrhoidectomy in grade III hemorrhoidal disease: the twisting trend. Langenbecks Arch Surg. 2023 Apr 5;408(1):140. doi: 10.1007/s00423-023-02879-4. |
| 38294832 | Background | Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available. |
| 37616177 | Background | Giuliani A, Romano L, Necozione S, Cofini V, Di Donato G, Schietroma M, Carlei F; EMODART3 Study Group. Excisional Hemorrhoidectomy Versus Dearterialization With Mucopexy for the Treatment of Grade III Hemorrhoidal Disease: The EMODART3 Multicenter Study. Dis Colon Rectum. 2023 Dec 1;66(12):e1254-e1263. doi: 10.1097/DCR.0000000000002885. Epub 2023 Aug 24. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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