Simethicone and Gynecological Laparoscopies: Does it Improve Operative Field and Postoperative Pain?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- five-point scale
研究概览
简要总结
Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.
The investigators objective is to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.
详细描述
Introduction
Simethicone is an oral antifoaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.
Objective
to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.
Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome measure will be the overall exposure of the surgical field and pain scoring. Assessment of the overall exposure of the surgical field was done using a five-point scale (poor, sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for assessment of postoperative pain and verbal analog scoring was used for assessment of patient satisfaction.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients
- •aged 20 - 40 years old
- •scheduled for laparoscopy
排除标准
- •Women were excluded from the study if patients had one or more of the following:
- •scar of previous operation, uterine mass, severe endometriosis, suspicion of malignancy, history of allergic reaction to study drugs, psychiatric disorders and patient refusal
研究组 & 干预措施
Simethicone
Arm 1 or Group I or Simethicone 40mg. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.
干预措施: Simethicone Tab 40 mg (Drug)
placebo
Arm 2 or group 2 or placebo group. 3 tablets (one tablet after each meal) and to fast overnight the day before the operation.
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
five-point scale
时间窗: 1 hour
次要结局
- Patient satisfaction(24 hours)
- VAS(24 hours)
- The degree of bowel preparation(1 hour)
研究者
Kamal Mohamed Zahran
Assistant professor of Obstetrics & Gynecology, Faculty of Medicine, Consultant and vice director, Women's Health Hospital, Assiut University, Egypt
Woman's Health University Hospital, Egypt