The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Jinling Hospital, China
- Enrollment
- 302
- Locations
- 1
- Primary Endpoint
- Prolonged ileus
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Jianfeng Gong
Associate Professor
Jinling Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
Exclusion Criteria
- •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
Arms & Interventions
Dexamethasone
Dexamethasone 8mg intravenously prior to anesthesia induction
Intervention: Dexamethasone
Control
Normal Saline 1.6ml intravenously prior to anesthesia induction
Intervention: Normal saline
Outcomes
Primary Outcomes
Prolonged ileus
Time Frame: 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.
Secondary Outcomes
- 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)