ACTRN12619001570178尚未招募未知
Efficacy of warm humidified insufflation for reducing post-operative ileus in patients undergoing acute general surgical laparotomy: A randomised single-blind controlled trial.
Fisher and Paykel Healthcare0 个研究点目标入组 226 人开始时间: 2019年11月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Patients aged at least 18 years;
- •Able to give informed consent and understand risks and benefits of the study;
- •Patients undergoing an elective, expedited, urgent, or emergency laparotomy lasting at least 60 minutes;
- •Laparotomy involving:
- •oThe stomach, small or large bowel, or rectum for perforation, ischaemia, abdominal abscess, bleeding, obstruction, or trauma
- •oWashout/evacuation of intra-peritoneal abscess;
- •oWashout/evacuation of intra-peritoneal haematoma;
- •oBowel resection/repair due to incarcerated incisional, umbilical, inguinal, and femoral hernias (but not hernia repair without bowel resection/repair);
- •oBowel resection/repair due to obstructing/incarcerated incisional hernias if the presentation and findings were acute (including large incisional hernia repair with division of adhesions);
- •oInoperable pathology (e.g. peritoneal/hepatic metastases), not including purely diagnostic procedures;
- •oPathology caused by blunt or penetrating trauma;
- •oPathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract;
- •oReturn to theatre for repair of substantial dehiscence of major abdominal wound;
- •oAny reoperation/return to theatre for complications of elective general/upper GI surgery meeting the above criteria;
- •Re-look laparotomies.
排除标准
- •Active inflammatory bowel disease
- •Moderate to severe renal impairment (eGFR<50mL/min/1.73m2)
- •Severe hepatic impairment (Child-Pugh C)
- •All other gynae and obstetrics patients
- •Pre-existing gut motility disorder including endocrine, metabolic or neurological cause
- •Pre-operative malnutrition requiring parenteral nutrition
- •Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium
- •Diagnostic laparotomy
- •Appendicectomy
- •Cholecystectomy
- •Hernia repair without bowel resection or division of adhesions
- •Minor abdominal wound dehiscence
- •Laparoscopic procedures
- •Vascular surgery
- •Sclerosing peritonitis
- •Removal of dialysis catheters
- •Oesophageal pathology
研究者
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