The Effect of Intraabdominal Saline Irrigation on Infectious Morbidities and Gastrointestinal Outcomes in Patients Undergoing Abdominal Hysterectomies for Benign Causes
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- postoperative infectious morbidities
研究概览
简要总结
The objective of this prospective randomised clinic study is to investigate the effect of peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative infectious morbidities and gastrointestinal disturbance. The participants will be randomised to either an irrigation of abdominal cavity or the control group after vaginal closure. Assignment to one of the two treatment groups will be determined using a computer generated random numbers. Primary outcome is the rate of postoperative infectious morbidities. Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment arm planned.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing hysterectomies for benign causes
排除标准
- •patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess
研究组 & 干预措施
Irrigation with saline solution
during abdominal hysterectomy after vaginal cuff closure abdominal saline irrigation will be done
干预措施: Irrigation with Saline Solution (Drug)
结局指标
主要结局
postoperative infectious morbidities
时间窗: 10 day after hysterectomy operation
vaginal cuff infection diagnosed with vagen cuff culture
次要结局
- gastrointestinal outcomes: nausea by questionnaire(postoperative first day)
- gastrointestinal outcome: vomiting by questionnaire(postoperative first day)
研究者
Nadiye Koroglu
Principal Investigator
Kanuni Sultan Suleyman Training and Research Hospital