The Effects of Fascial Closure Techniques on Post-Operative Pain in Gynecologic Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post-operative incisional pain
研究概览
简要总结
This study compares post-operative incisional pain on post-operative days 1 and 7 who will undergo gynecologic laparoscopic operations. Half of participants will undergo conventional fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl Storz, Belgium).
详细描述
Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy. The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer the techniques in fascial closure which is more safe and cause less pain. In current study, investigators aim to compare the post-operative incisional pain in two different techniques in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years
- •Ability to understand the inform consent
- •No conversion from laparoscopy to laparotomy
排除标准
- •No-ability to understand the inform consent
- •Conversion to laparotomy from laparoscopy
研究组 & 干预措施
Conventional Technique
The edges of the fascia will be hold by the surgical instruments. The fascial defect will be repaired by using devices which are generated for laparotomy operations.
干预措施: Conventional technique (Procedure)
Berci Technique
This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.
干预措施: Berci technique (Procedure)
结局指标
主要结局
Post-operative incisional pain
时间窗: 7 days after fascial closure closure
Visual Analog Scale
次要结局
- Time for fascial closure(Intraoperative)
研究者
Hasan Onur Topçu
Associate Professor
Zekai Tahir Burak Women's Health Research and Education Hospital