Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- operative time
研究概览
简要总结
A comparison study was performed between Ligasure and Milligan morgan hemorrhoidectomy to find out the outcome between these two techniques in 3rd and 4th degree hemorrhoids.This advance vessel sealing device is used to seal the pedicle of the vessel and does not burn the surrounding tissues , so the outcome was monitored in terms of operative time, post operative pain pain, duration of wound healing in 3 weeks and return to normal activities
详细描述
INTRODUCTION:
Milligan Morgan hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in ligasure hemorrhoidectomy have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time, wound healing and return to normal activities.
OBJECTIVES:
To compare the outcome of ligasure hemorrhoidectomy with conventional hemorrhoidectomy in III and IV degree hemorrhoids.
STUDY DESIGN:
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
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with III and IV degree hemorrhoids assessed on proctoscopy had been included in this study.
排除标准
- •Patients with permanently prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
- •Any other anorectal pathology on history and per rectal examination
- •Previous anal surgery assessed by history and per rectal examination
- •Inability to give informed consent
- •ASA(American Society of Anesthesiologists) grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic and renal profile and evidence of ischemic heart disease
研究组 & 干预措施
CH(conventional Hemorrhoidectomy)
conventional hemorrhoidectomy
干预措施: Hemorrhoidectomy (Procedure)
LH (Ligasure Hemorrhoidectomy)
Ligasure hemorrhoidectomy
干预措施: Hemorrhoidectomy (Procedure)
结局指标
主要结局
operative time
时间窗: each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes
was measured from start of incision to the dressing in minutes
wound healing
时间窗: to assess change in the parameter in 3 weeks
assessed in scheduled appointment every week and has been defined as complete epithelization on physical examination .Wound was graded as 1-sloughy, 2-no granulation, 3-granulation, 4-epithelizing , 5-completely epithelized
mean postoperative pain
时间窗: each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours
on Visual analogue scale,a scale to assess the post operative pain ,8-10 as maximum pain, 5-7 as moderate pain, 2-4 minimum pain, 1-0 as no pain and change in final outcome has been assessed after 48 hours
Return to work
时间窗: assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days
has been defined as day of discharge till resume of work that is patient is able to perform daily routine activities normally as before operation.
次要结局
未报告次要终点
研究者
Safia Zahir Ahmed
principal investigator
Services Hospital, Lahore