Hemorrhoidectomy, Energy-Based, and Laser Outcomes in Grade III Hemorrhoids: A Prospective, Multicenter, Preference-Based Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to Functional Recovery
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Other anorectal diseases (fistula, abscess, IBD, malignancy).
- •Prior anorectal surgery within 6 months.
- •Pregnancy or lactation.
- •Contraindications to anesthesia.
研究组 & 干预措施
Conventional Hemorrhoidectomy
Standard closed excisional hemorrhoidectomy
干预措施: Ferguson Hemorrhoidectomy (Procedure)
Laser Hemorrhoidoplasty (LHP)
1470nm or 980nm diode laser ablation
干预措施: Laser Hemorrhoidoplasty (LHP) (Procedure)
Hemorrhoid Energy Therapy (HET)
Bipolar radiofrequency coagulation using HET™ system
干预措施: Hemorrhoid Energy Therapy (HET) (Procedure)
结局指标
主要结局
Time to Functional Recovery
时间窗: Up to 1 month post-operation
Days to return to work or normal daily activities.
Post-operative Pain Trajectory (Area Under the Curve)
时间窗: Post-operative Day 1 to Day 14
Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).
次要结局
- Recurrence Rate(12 months post-operation)
研究者
I-Li Lai, MD
Assistant Professor
Chang Gung Memorial Hospital
