NCT01297725已完成不适用
Sharp Versus Blunt Fascial Incision at Caesarean Section: A Prospective Randomized Double-blinded Case-Control Study With the Case as it's Own Control.
Holbaek Sygehus4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Preferred side of the scar evaluated by the patient 3 months postoperatively
研究概览
简要总结
The purpose of this study is to compare sharp and blunt fascial entry during caesarean section on the same patient. The study is performed on woman having cesarean section for the first time and who have not previously had lower abdominal surgery done. The following parameters are registered:
- The preferred side evaluated by the patient 3 months postoperatively.
- The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.
- The rate and side of infection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman having caesarean section for the first time
- •Woman, who have had no previous lower abdominal surgery
- •Woman who speak and understand Danish
- •Woman who can give informed consent
排除标准
- •Diabetes Mellitus (This does not include gestational diabetes)
- •Infection
- •Regular treatment with immunosuppressives
- •Alcohol or drug abuse
- •Age under 18 years old
- •Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
- •BMI over 35
结局指标
主要结局
Preferred side of the scar evaluated by the patient 3 months postoperatively
时间窗: 3 months
The overall preference of scar side - left, right or no difference - taking the entire postoperative 3 months into account as evaluated by the patient.
次要结局
- The difference in pain between the two sides of the scar(1 and 3 months postoperatively)
- Pain on the two sides of the scar(1, 3 and 7 days postoperatively)
- Pain in the two sides of the scar(1 and 3 months postoperatively)
- Infection(1 and 3 months postoperatively)
研究者
Anna Aabakke
Anna Aabakke
Holbaek Sygehus
研究点 (4)
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