HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids

Официальное название

Hemorrhoidectomy, Energy-Based, and Laser Outcomes in Grade III Hemorrhoids: A Prospective, Multicenter, Preference-Based Comparative Study

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Laser Hemorrhoidoplasty (LHP)
  1470nm or 980nm diode laser ablation
• Процедура Hemorrhoid Energy Therapy (HET)
  Bipolar radiofrequency coagulation using HET™ system
• Процедура Ferguson Hemorrhoidectomy
  Standard closed excisional hemorrhoidectomy

Первичные конечные точки

• Time to Functional Recovery [Срок оценки: Up to 1 month post-operation]
• Post-operative Pain Trajectory (Area Under the Curve) [Срок оценки: Post-operative Day 1 to Day 14]

Вторичные конечные точки (1)

• Recurrence Rate [Срок оценки: 12 months post-operation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Other anorectal diseases (fistula, abscess, IBD, malignancy).
• Prior anorectal surgery within 6 months.
• Pregnancy or lactation.
• Contraindications to anesthesia.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Chang Gung Memorial Hospital, Linkou Branch — Taoyuan

Публикации

• 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. PMID 39952268
• 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/s00423-023-02 PMID 37020091
• 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 abs PMID 38294832
• 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. PMID 37616177

Идентификаторы

NCT: NCT07333040 · 202501172A3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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