Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Wound infection
研究概览
简要总结
the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.
详细描述
• Study Hypothesis: - Using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis.
Type of study: - Randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of Alzhraa University Hospital of faculty of Medicine for girls - Cairo within 1 year according to sample size. A computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment.
Participants at morning of the operation will be given information about the study aims and written consent will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for elective gynecological abdominal surgeries for benign diseases
- •willing to participate in the study.
- •The participants will receive 2 gm cephalosporines preoperative per hospital policy.
排除标准
- •History of receiving antibiotics during the preceding 7 days,
- •chronic medical illness like diabetes, asthma or tuberculosis,
- •patients have anemia,
- •surgically scarred tissues,
- •Immuno-compromised patients,
- •pregnant patients,
- •patients with pacemaker device,
- •patients on anticoagulants therapy
结局指标
主要结局
Wound infection
时间窗: after surgery till primary healing of the wound, an average of 15 days after operation
rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever
Wound incision time
时间窗: at the beginning of each surgery
measure time needed to open anterior abdominal wall in minutes by stopwatch
次要结局
- Amount of Analgesia needed during 1st 12 hr after surgery .(first 12 hours after surgery)
- Postoperative pain (pain score 2-4 hr postoperative).(during first 4 hours after surgery)
- Wound-related blood loss(after opening anterior abdominal wall during each surgery)
- number of participants with bad scar formation or keloid(through study completion, an average of 1.25 year)
研究者
Shimaa Esmail Borhamy Khalaf
Principal Investigator
Al-Azhar University