A Phase 2 interventional study of Dexamethasone and Normal saline in Inflammatory Bowel Diseases, Dexamethasone and Postoperative Ileus, sponsored by Jinling Hospital, China. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Jinling Hospital, China · Phase 2, Interventional, and Treatment
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.
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
Exclusion Criteria:
Dexamethasone 8mg intravenously prior to anesthesia induction
Drug: Dexamethasone
Normal Saline 1.6ml intravenously prior to anesthesia induction
Drug: Normal saline
Dexamethasone 8mg intravenously prior to induction of anesthesia
Normal saline 1.6ml intravenously prior to induction of anesthesia
Prolonged ileus
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.
Time frame: Day 30
PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery
the incidence of any nausea, emetic episodes (retching or vomiting),or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.
Time frame: 24hr
Postoperative pain on POD 1, 3, and 5
Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)
Time frame: up to 1 week
Postoperative fagitue score on POD 1, 3, and 5
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (Version 4). The FACIT-IT score is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
Time frame: up to 1 week
GI-2 recovery
time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).
Time frame: Day 30
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Blood WBC levels, preoperative and on postoperative 1,3 and 5
Time frame: Day 30
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5
Time frame: Day 30
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5
Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and
Time frame: Day 30
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5
Time frame: Day 30
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5
Time frame: Day 30
Body composition, preoperative and on POD 1
body composition was determined using Bioelectrical impedance analysis (BIA)
Time frame: Day 30
Postoperative length of stay
in days
Time frame: Day 90
Postoperative morbidity
Documented using comprehensive complication index(CCI)
Time frame: Day 30
Postoperative surgical site infections (SSIs)
Including superficial SSIs and deep SSIs.
Time frame: Day 30
Overall cost of treatment
In Chinese Yuan (CNY)
Time frame: up to 1 year
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Jinling Hospital, China