Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
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
- post operative pain
研究概览
简要总结
Hemorrhoidectomy is the treatment of choice for grade 3 and 4th degree hemorrhoids. Various surgical technique has been used to improve the outcome of the procedures performed in respect to operative time ,post operative pain and hospital stay. This study compares the conventional closed technique with harmonic scalpel technique which is a device regulated with ultrasonic waves to perform the procedure with minimal postoperative complication as well as decreasing the prolong stay in hospital.
详细描述
INTRODUCTION:
Ferguson closed hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in harmonic scalpel have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time and duration of hospital stay.
OBJECTIVES:
To compare the outcome of conventional hemorrhoidectomy versus harmonic scalpel 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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.
排除标准
- •• Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
- •Any other anorectal pathology such as anal fissure ,fistula or anal cancer on history and per rectal examination
- •Previous anal surgery assessed by history and per rectal examination
- •Inability to give informed consent
- •ASA grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic(AST/ALT >40IU/L) and renal profile ( creatinine >1:2mg/dl)and evidence of ischemic heart disease(annexure attached).
研究组 & 干预措施
CH( Conventional Hemorrhoidectomy)
Closed Conventional Hemorrhoidectomy
干预措施: Hemorrhoidectomy (Procedure)
HS( Harmonic Scalpel)
Harmonic Scalpel Hemorrhoidectomy
干预措施: Hemorrhoidectomy (Procedure)
结局指标
主要结局
post operative pain
时间窗: Each Patient was measured in 24 hours
On Visual analogue scale, a scale to measure pain and it ranges between 0-10. Scale 0-1 means no pain, 2-4 means mild pain,5-7 means moderate pain and 8-10 means severe pain. and it was measured post-operative in 24 hours
Operative Time
时间窗: The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes
from start of incision to the dressing in minutes
Hospital Stay
时间窗: the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days
was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (\<3)
次要结局
未报告次要终点
研究者
Safia Zahir Ahmed
principal Investigator
Services Hospital, Lahore