Dexamethasone, Inflammatory Bowel Diseases, Postoperative Complications, Postoperative Ileus
Conditions
Keywords
Inflammatory Bowel Diseases, Glucocorticosteroids, Postoperative Outcome
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
Interventions
DRUGDexamethasone
Dexamethasone 8mg intravenously prior to induction of anesthesia
DRUGNormal saline
Normal saline 1.6ml intravenously prior to induction of anesthesia
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC). 2. ASA I-III
Exclusion criteria
1. Diabetes or hyperglycemia 2. Active gastric ulceration confirmed endoscopically 3. Presence of ongoing infection (such as IAS) or infective chronic diseases 4. Currently receiving systemic therapy with glucocorticoids with prednisolone \>=20mg for over 6 weeks within 30 days prior to surgery. 5. Emergent surgery 6. Acute angle glaucoma 7. Pregnancy 8. Under 18 years of age 9. Known adverse reaction to dexamethasone 10. Extensive adhesiolysis 11. Carcinogenesis of intestinal tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged ileus | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain on POD 1, 3, and 5 | up to 1 week | Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale) |
| Postoperative fagitue score on POD 1, 3, and 5 | up to 1 week | 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) |
| GI-2 recovery | Day 30 | time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2). |
| Blood WBC levels, preoperative and on postoperative 1,3 and 5 | Day 30 | Blood WBC levels, preoperative and on postoperative 1,3 and 5 |
| Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5 | Day 30 | Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5 |
| Serum C-reactive protein (CRP) level, preopperative and on postoperative 1,3 and 5 | Day 30 | 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 |
| PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery | 24hr | the incidence of any nausea, emetic episodes (retching or vomiting),or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours. |
| Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5 | Day 30 | Serum procalcitonin (PCT) level, preopperative and on postoperative 1,3 and 5 |
| Body composition, preoperative and on POD 1 | Day 30 | body composition was determined using Bioelectrical impedance analysis (BIA) |
| Postoperative length of stay | Day 90 | in days |
| Postoperative morbidity | Day 30 | Documented using comprehensive complication index(CCI) |
| Postoperative surgical site infections (SSIs) | Day 30 | Including superficial SSIs and deep SSIs. |
| Overall cost of treatment | up to 1 year | In Chinese Yuan (CNY) |
| Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5 | Day 30 | Serum Interleukin-6 (IL-6) level, preopperative and on postoperative 1,3 and 5 |
Countries
China
Outcome results
None listed