Perioperative Dexamethasone on Postoperative Outcome in IBD

Study Overview
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Brief Summary
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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
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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

Official Title
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The Impact of Perioperative Dexamethasone on Postoperative Outcome in Inflammatory Bowel Diseases.

Conditions
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Inflammatory Bowel Diseases, Dexamethasone, Postoperative Ileus, Postoperative Complications

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC). ASA I-III 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 Pregnancy Under 18 years of age Known adverse reaction to dexamethasone Extensive adhesiolysis Carcinogenesis of intestinal tract

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Dexamethasone 8mg intravenously prior to anesthesia induction | Drug: Dexamethasone<br>* Dexamethasone 8mg intravenously prior to induction of anesthesia<br>|
| Placebo Comparator: Control<br>Normal Saline 1.6ml intravenously prior to anesthesia induction | Drug: Normal saline<br>* Normal saline 1.6ml intravenously prior to induction of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24hr | 
| Postoperative pain on POD 1, 3, and 5 | Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale) | 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) | up to 1 week | 
| GI-2 recovery | time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2). | Day 30 | 
| Blood WBC levels, preoperative and on postoperative 1,3 and 5 | Blood WBC levels, preoperative and on postoperative 1,3 and 5 | Day 30 | 
| Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5 | 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 | 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 | 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 | 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 | Day 30 | 
| Body composition, preoperative and on POD 1 | body composition was determined using Bioelectrical impedance analysis (BIA) | Day 30 | 
| Postoperative length of stay | in days | Day 90 | 
| Postoperative morbidity | Documented using comprehensive complication index(CCI) | Day 30 | 
| Postoperative surgical site infections (SSIs) | Including superficial SSIs and deep SSIs. | Day 30 | 
| Overall cost of treatment | In Chinese Yuan (CNY) | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases, Glucocorticosteroids, Postoperative Outcome