Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
This prospective cohort study evaluates whether combining "suture mucopexy" (a simple stitch-based lift of prolapsed tissue) with Laser Hemorrhoidoplasty (LHP) can effectively relieve pain, bleeding and prolapse in adults with moderate-to-severe hemorrhoids (Grades II-IV). Participants will undergo the combined, non-Doppler-guided procedure and be followed for one year. The primary question is how long patients need post-operative pain medication and if they first experience complete symptom relief; secondary questions examine quality-of-life, safety (bleeding, urinary retention, stenosis) and the rate of hemorrhoid recurrence/re-operation.
详细描述
Laser Hemorrhoidoplasty (LHP) offers a minimally invasive option for symptomatic hemorrhoids, yet in advanced disease (Goligher III/IV) recurrence rates of 20-35 % have been reported because residual mucosal prolapse persists. Adding a suture-based mucopexy (SM) eliminates the prolapse and ligates feeding vessels without the need for Doppler guidance, thereby potentially reducing recurrence while preserving the low-pain advantage of LHP. Preliminary experience with 50 patients at this centre demonstrated feasibility, low early complication rates, and promising symptom control, justifying a formal prospective evaluation.
The present study is a single-center, prospective observational cohort enrolling consecutive eligible adults over a 24-month accrual period. All participants receive the same combined LHP + SM technique; no comparator arm is planned. Follow-up visits occur at postoperative week 6, month 6 and month 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years).
- •Symptomatic Hemorrhoidal Disease (Goligher Grades II, III, IV).
- •Patients with or without recurrent disease after prior procedures (e.g., RBL, infrared coagulation, Milligan-Morgan, etc).
排除标准
- •Acutely thrombosed hemorrhoids.
- •Concomitant anal fistula or abscess requiring separate surgical management.
- •IBD (Crohn's/Ulcerative Colitis) with active rectal involvement.
- •Previous Stapled Haemorrhoidopexy (SH/Longo).
结局指标
主要结局
Duration of analgesia
时间窗: perioperatively
Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications.
Primary Symptom Relief
时间窗: perioperatively
Patient-reported cessation of bleeding and/or pain.
次要结局
- Morbidity(3 months)
- Complications(12 months)
- Reoperation Rate(12 months)
- Nyström Hemorrhoid Severity Score (HSS)(12 months)
研究者
George Theodoropoulos
Professor
National and Kapodistrian University of Athens