The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Prolonged ileus
研究概览
简要总结
The objective of this RCT is to determine the efficacy of a single preoperative dose of Dexamethasone for accelerating the recovery and reducing the incidence of postoperative complications in adult patients undergoing intestinal resection for inflammatory bowel disease.
详细描述
Patients undergoing surgery for IBD is associated with increased inflammatory response and incidence of prolonged ileus after surgery compared to other colorectal disease such as CRC. Previous studies have revealed that preoperative administration of glucocorticosteroids(GCs) decreased complications and length of postoperative length of hospital after major abdominal surgery as a likely consequence of attenuating the postsurgical inflammatory response. Also, a single dose of GCs did not increase complications in colorectal surgery. The aim of the study is to examine whether a single dose of dexamethasone prior to induction of anesthesia could promote the recovery of patients and reduce the incidence of prolonged ileus after surgery for IBD
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
排除标准
- •Diabetes or hyperglycemia
- •Active gastric ulceration confirmed endoscopically
- •Presence of ongoing infection (such as IAS) or infective chronic diseases
- •Currently receiving systemic therapy with glucocorticoids with prednisolone >=20mg for over 6 weeks within 30 days prior to surgery.
- •Emergent surgery
- •Acute angle glaucoma
- •Under 18 years of age
- •Known adverse reaction to dexamethasone
- •Extensive adhesiolysis
- •Carcinogenesis of intestinal tract
研究组 & 干预措施
Dexamethasone
Dexamethasone 8mg intravenously prior to anesthesia induction
干预措施: Dexamethasone (Drug)
Control
Normal Saline 1.6ml intravenously prior to anesthesia induction
干预措施: Normal saline (Drug)
结局指标
主要结局
Prolonged ileus
时间窗: Day 30
Prolonged POI was defined as if two or more of the following five criteria are met on day 4 postoperatively: nausea or vomiting; inability to tolerate an oral diet over last 24 h; absence of flatus over last 24 h; abdominal distension; and radiologic confirmation.
次要结局
- Postoperative pain on POD 1, 3, and 5(up to 1 week)
- PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery(24hr)
- Blood WBC levels, preoperative and on postoperative 1,3 and 5(Day 30)
- Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5(Day 30)
- Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5(Day 30)
- Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5(Day 30)
- Postoperative fagitue score on POD 1, 3, and 5(up to 1 week)
- GI-2 recovery(Day 30)
- Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5(Day 30)
- Body composition, preoperative and on POD 1(Day 30)
- Postoperative length of stay(Day 90)
- Postoperative morbidity(Day 30)
- Postoperative surgical site infections (SSIs)(Day 30)
- Overall cost of treatment(up to 1 year)
研究者
Jianfeng Gong
Associate Professor
Jinling Hospital, China