Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Pain evaluation
研究概览
简要总结
the study aims to evaluate the effectiveness and long term outcomes of laser hemorroidoplasty versus conventional milligan morgan hemorrhoidectomy in II-III degree hemorroidal disease.
详细描述
Background Hemorrhoidal disease (HD) is a widespread condition and several surgical techniques have been proposed to date without achieving a definitive consensus. Laser Hemorrhoidoplasty (LHP) is a minimal invasive procedure for HD treatment determining the shrinkage of the hemorrhoidal piles by diode laser limiting the postoperative discomfort and pain. The aim of the current prospective randomized trial is to evaluate the postoperative outcomes of HD patients undergoing LHP vs conventional Milligan-Morgan hemorrhoidectomy (MM).
Methods. Operative time, postoperative pain and complications, resolution of symptoms, patients 'quality of life, patients' evaluation of treatment and length of return to daily activity of II-III grade symptomatic HD patients undergoing LHP vs MM were prospectively evaluated. The patients were followed-up for 24 months looking for recurrence of prolapsed hemorrhoid or symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •II-III hemorrhoidal disease
- •failure of conservative treatment
排除标准
- •acutely thrombosed hemorrhoids
- •patients affected by IBD involving rectum or anus
- •patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol
结局指标
主要结局
Pain evaluation
时间窗: 30 postoperative days.
postoperative pain assessment with Visual Analogue Scale Score
Analgesic use
时间窗: 30 postoperative days.
use of analgesic drugs in the postopertive days
次要结局
- Presence of recurrence(24 months)
研究者
Claudio Gambardella
Principal Investigator
University of Campania "Luigi Vanvitelli"