NCT03456752.
| Trial name or title | The impact of perioperative dexamethasone on postoperative outcome in inflammatory bowel diseases. |
| Methods | A randomised, double‐blind, placebo‐controlled study |
| Participants | 302 adults (aged 18 ‐ 75 years) undergoing elective open and laparoscopic small and large bowel operations for IBD, including CD and UC |
| Interventions | Experiment: Dexamethasone 8 mg intravenously prior to anaesthesia induction Comparator: Placebo of normal saline 8 mg intravenously prior to anaesthesia induction |
| Outcomes | Primary outcome: Prolonged ileus (defined as 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 nausea and vomiting, and additional antiemetics given within 24 hr after surgery Postoperative pain on postoperative day (POD) 1, 3, and 5 (VAS for pain) Postoperative fatigue on POD 1, 3, and 5 (FACIT‐F) GI‐2 recovery (time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery) Blood WBC levels (preoperative and on POD 1, 3 and 5) Blood neutrophil percentage (preoperative and on POD 1, 3 and 5) Serum C‐reactive protein (CRP) level (preoperative and on POD 1, 3 and 5) Serum Interleukin‐6 (IL‐6) level (preoperative and on POD 1, 3 and 5) Serum procalcitonin (PCT) (preoperative and on POD 1, 3 and 5) Body composition (bioelectrical impedance analysis (BIA) preoperative and on POD 1) Postoperative length of stay in days Postoperative morbidity (comprehensive complication index (CCI)) Postoperative surgical site infections (SSIs) (superficial SSIs and deep SSIs) Overall cost of treatment (in Chinese Yuan) |
| Starting date | June 2018 |
| Contact information | Jianfeng Gong, MD, Department of General Surgery, Jinling Hospital, Medical School of Nanjing University Nanjing, Jiangsu, China 210000 +86‐25‐80860036 gongjianfeng@hotmail.com |
| Notes | Estimated study completion date: October 2019 Estimated enrollment: 302 participants |